260 Ofertas de Drug Safety en España

Senior Drug Safety Physician / Drug Safety Physician Senior Drug Safety Physician / Drug Safety Physician

Location: Remote (Spain). Regular Full-time, Division: Precision for Medicine, Business Unit: Clinical Solutions. Requisition Number: 5457. Precision for Medicine is hiring an experienced Drug Safety Physician with line management experience to join our team. Candidates can be based in the UK, Serbia or Spain.

Position Summary: The Drug Safety Physician will be responsible for the pharmacovigilance function, including medical review and oversight of processing for all types of safety events. The individual will provide clinical support of drug safety data management and interpretation and risk management activities for the company, including oversight of clinical trial Serious Adverse Event (SAE) processing and safety data analysis to support signal detection and risk/benefit profile evaluation. This individual will ensure timely, consistent, and accurate safety reporting in accordance with FDA, EMA, and ICH guidelines, applicable regulatory requirements, Good Clinical Practice (GCP) and standard operating procedures (SOPs).

• Manage all aspects of Drug Safety and Pharmacovigilance, including leadership of safety data review, signal detection, risk communication including safety information updates, and mitigation of potential risks
• Provide medical and drug safety expertise to enable decision-making based on ongoing risk-benefit assessment, clinical trial data interpretation, and medical review of individual case reports of SAEs
• Work with CRO Safety Physicians / Team and Dragonfly’s Medical Directors, Clinical Scientists and other functions on safety monitoring, assessment and reporting activities (case and aggregate)
• Input on safety sections in cross-functional documents (eg, study protocols, study reports, IBs, ICFs) and on responses to safety-related questions from regulatory agency, IRBs and Ethics Committees
• Act as the point of contact accountable for setting up and running DSMBs or safety data review meetings
• Participate in routine safety cohort reviews for ongoing Phase 1 dose escalation studies
• Perform event coding review and clinical & safety database reconciliation for consistent coding
• Oversee and manage Drug Safety system(s) to ensure compliance with safety data management and reporting requirements in all relevant territories and optimized safety database ownership and access for safety monitoring, signal detection and reporting
• Ensure effective SOPs and strong safety vendor governance are in place
• Proactively recommend and plan for future development of Drug Safety and Pharmacovigilance to enable regulatory filings and commercialization, including acquiring QPPV support and the participation in creating Risk Management Plans and a Pharmacovigilance System Master File
• Ensure audit and inspection readiness of the function at all times

• MD required, with a minimum of 7 years in Drug Safety related activities in pharma / biotech
• Clinical trial experience, including oncology drug safety with least 3 years being in early clinical development
• Experience authoring, reviewing, and providing input to drug-safety related regulatory reports
• Successful involvement in regulatory agency interactions or inspections
• Strong knowledge of FDA, EU, ICH and other global regulatory requirements for safety reporting and safety data and risk management
• Solid medical knowledge and familiarity with medical concepts and terminology used in hematology / oncology clinical trials and safety monitoring
• Proficiency with using standard computer applications (eg Microsoft Office, Windows) and safety databases
• Possesses a sense of urgency and an ability to anticipate and respond quickly to emerging information
• Excellent oral and written communication skills for effectively interfacing with vendors and internal stakeholders
• Fosters strong relationships and values collaboration to develop and execute on plans
• Ability to multi-task in a fast-paced environment
• Self-motivated, conscientious, and enthusiastic about curing human diseases

• Experience with case processing in ARGUS
• Demonstrated ability to challenge existing practices to become more effective.
• Ability to effectively adapt to a variety of situations.
• Meet quality and performance standards.
• Excellent communication skills, both written and oral
• Work effectively as a team member and promotes collaboration.
• Demonstrate ownership, initiative and accountability.
• Supervisory experience
• Less than 20% travel.
• Ability to deliver on commitments and understanding of service culture.
• Communicates effectively and efficiently on safety issues to internal and external stakeholders.
• Maintain consistency of safety assessments.
• Serve in cross-functional teams as Drug Safety expert.
• Monitor regulatory compliance of safety reporting throughout trial.
• Lead and contribute to process development and / or process improvements that support Drug Safety

Precision medicine is revolutionizing the attack on cancer—and we are passionate about helping you harness its power. We strike tumors on a molecular level using biomarkers to link specific mutations to specific treatments. We combine deep science with deep data from advanced technological platforms, then layer on specialized expertise in the design and execution of targeted, adaptive clinical trials. Ultimately, we deliver robust insights that inform real-time decisions—and optimize the oncology development pathway.

It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.

Apply Now

Seniority level

• Senior level

Employment type

• Full-time

Job function

• Health Care Provider

Industries

• Business Consulting and Services

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Sign in to set job alerts for “Senior Physician” roles.

Madrid, Community of Madrid, Spain • Ibiza, Balearic Islands, Spain • Madrid, Community of Madrid, Spain • Valladolid, Castilla and Leon, Spain • Burgos, Castilla and Leon, Spain • Álava, Principality of Asturias, Spain • Nava, Principality of Asturias, Spain • Oviedo, Principality of Asturias, Spain • Salamanca, Castilla and Leon, Spain • Villafranca, Castilla and Leon, Spain

Ávila, Castilla and Leon, Spain

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J-18808-Ljbffr

Overview

Senior Drug Safety Physician / Drug Safety Physician Senior Drug Safety Physician / Drug Safety Physician

Location: Remote (Spain). Regular Full-time, Division: Precision for Medicine, Business Unit: Clinical Solutions. Requisition Number: 5457. Precision for Medicine is hiring an experienced Drug Safety Physician with line management experience to join our team. Candidates can be based in the UK, Serbia or Spain.

Position Summary: The Drug Safety Physician will be responsible for the pharmacovigilance function, including medical review and oversight of processing for all types of safety events. The individual will provide clinical support of drug safety data management and interpretation and risk management activities for the company, including oversight of clinical trial Serious Adverse Event (SAE) processing and safety data analysis to support signal detection and risk/benefit profile evaluation. This individual will ensure timely, consistent, and accurate safety reporting in accordance with FDA, EMA, and ICH guidelines, applicable regulatory requirements, Good Clinical Practice (GCP) and standard operating procedures (SOPs).

• Manage all aspects of Drug Safety and Pharmacovigilance, including leadership of safety data review, signal detection, risk communication including safety information updates, and mitigation of potential risks
• Provide medical and drug safety expertise to enable decision-making based on ongoing risk-benefit assessment, clinical trial data interpretation, and medical review of individual case reports of SAEs
• Work with CRO Safety Physicians / Team and Dragonfly’s Medical Directors, Clinical Scientists and other functions on safety monitoring, assessment and reporting activities (case and aggregate)
• Input on safety sections in cross-functional documents (eg, study protocols, study reports, IBs, ICFs) and on responses to safety-related questions from regulatory agency, IRBs and Ethics Committees
• Act as the point of contact accountable for setting up and running DSMBs or safety data review meetings
• Participate in routine safety cohort reviews for ongoing Phase 1 dose escalation studies
• Perform event coding review and clinical & safety database reconciliation for consistent coding
• Oversee and manage Drug Safety system(s) to ensure compliance with safety data management and reporting requirements in all relevant territories and optimized safety database ownership and access for safety monitoring, signal detection and reporting
• Ensure effective SOPs and strong safety vendor governance are in place
• Proactively recommend and plan for future development of Drug Safety and Pharmacovigilance to enable regulatory filings and commercialization, including acquiring QPPV support and the participation in creating Risk Management Plans and a Pharmacovigilance System Master File
• Ensure audit and inspection readiness of the function at all times

• MD required, with a minimum of 7 years in Drug Safety related activities in pharma / biotech
• Clinical trial experience, including oncology drug safety with least 3 years being in early clinical development
• Experience authoring, reviewing, and providing input to drug-safety related regulatory reports
• Successful involvement in regulatory agency interactions or inspections
• Strong knowledge of FDA, EU, ICH and other global regulatory requirements for safety reporting and safety data and risk management
• Solid medical knowledge and familiarity with medical concepts and terminology used in hematology / oncology clinical trials and safety monitoring
• Proficiency with using standard computer applications (eg Microsoft Office, Windows) and safety databases
• Possesses a sense of urgency and an ability to anticipate and respond quickly to emerging information
• Excellent oral and written communication skills for effectively interfacing with vendors and internal stakeholders
• Fosters strong relationships and values collaboration to develop and execute on plans
• Ability to multi-task in a fast-paced environment
• Self-motivated, conscientious, and enthusiastic about curing human diseases

• Experience with case processing in ARGUS
• Demonstrated ability to challenge existing practices to become more effective.
• Ability to effectively adapt to a variety of situations.
• Meet quality and performance standards.
• Excellent communication skills, both written and oral
• Work effectively as a team member and promotes collaboration.
• Demonstrate ownership, initiative and accountability.
• Supervisory experience
• Less than 20% travel.
• Ability to deliver on commitments and understanding of service culture.
• Communicates effectively and efficiently on safety issues to internal and external stakeholders.
• Maintain consistency of safety assessments.
• Serve in cross-functional teams as Drug Safety expert.
• Monitor regulatory compliance of safety reporting throughout trial.
• Lead and contribute to process development and / or process improvements that support Drug Safety

Precision medicine is revolutionizing the attack on cancer—and we are passionate about helping you harness its power. We strike tumors on a molecular level using biomarkers to link specific mutations to specific treatments. We combine deep science with deep data from advanced technological platforms, then layer on specialized expertise in the design and execution of targeted, adaptive clinical trials. Ultimately, we deliver robust insights that inform real-time decisions—and optimize the oncology development pathway.

It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.

Apply Now

Seniority level

• Senior level

Employment type

• Full-time

Job function

• Health Care Provider

Industries

• Business Consulting and Services

Referrals increase your chances of interviewing at Precision Value & Health by 2x

Sign in to set job alerts for “Senior Physician” roles.

Madrid, Community of Madrid, Spain • Ibiza, Balearic Islands, Spain • Madrid, Community of Madrid, Spain • Valladolid, Castilla and Leon, Spain • Burgos, Castilla and Leon, Spain • Álava, Principality of Asturias, Spain • Nava, Principality of Asturias, Spain • Oviedo, Principality of Asturias, Spain • Salamanca, Castilla and Leon, Spain • Villafranca, Castilla and Leon, Spain

Ávila, Castilla and Leon, Spain

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J-18808-Ljbffr

Overview

Be part of the future of drug safety at Asphalion. We're looking for a Drug Safety Officer ready to embrace new challenges in a fast-moving, international environment. If you thrive on precision and want to make a real impact, we'd love to have you on our team.

• Perform weekly global / local literature assessments.
• Efficiently manage Individual Case Safety Reports (ICSRs), Adverse Events (AEs), and follow-up activities.
• Manage cases through the Pharmacovigilance Database and report accurately to European authorities via EudraVigilance.
• Translate relevant pharmacovigilance information into English and liaise with Spanish Regulatory Authorities.
• Provide support to local and EU Qualified Persons for Pharmacovigilance (EUQPPv).
• Stay informed about updates in global and local pharmacovigilance regulations.
• Oversee the maintenance of the PSMF and Asphalion's Pharmacovigilance System (SOPs).
• Prepare and review PSURs, RMPs, DSURs, and ACOs with attention to detail.
• Offer expert medical advice and support Medical Information projects.
• Draft and review Pharmacovigilance agreements and provide strategic insights.
• Prepare and conduct internal Pharmacovigilance training sessions.

• 2 years experience in Pharmacovigilance departments.
• Fluent in English & Spanish
• Advanced IT level – (MS Office)
• Academic Degree in Life Science and Pharmacovigilance.
• Proactive, good communication, accurate, detail orientated, teamwork.

• Permanent contract.
• Flexible working schedule - Friday until 15.30h.
• Homeoffice & Hybrid or Remote Model
• You can be located anywhere in Spain)
• Wide variety of projects, new challenges and experiences.
• Training and personal development program.
• English lessons.

A professional, inclusive and high-performance work environment to develop your skills and grow your career. A great company culture built around Passion, Flexibility, Commitment, Quality & Companionship.

A highly & dynamic working environment with employees from more than 15 nationalities.

Our people and their well-being are our priority : Physical, psychological and emotional well-being programme.

Internal activities & RSC Activities

The Senior Pharmacovigilance Specialist (Sr PV Specialist) reports to the PV Associate Director and is responsible for the daily case management activities for assigned country(ies).

The PV Senior Specialist handles all PV activities, including aggregate and individual case safety report (ICSR) submissions to health authorities, compliance monitoring, and may serve as the PV contact with local stakeholders, headquarters (HQ), and local health authorities. The role involves collaborating with colleagues to ensure compliance with local laws and regulations, backing up colleagues, and adjusting schedules to prevent gaps in adverse event reporting and safety oversight.

Additional responsibilities (delegated/assigned by the Manager) may include PV intake, negotiation of local PV agreements, due diligence activities, audits and inspections, review of local initiatives for PV compliance, SOP management, local training, communication of safety issues, people development, and special projects, often working independently.

The Sr. Specialist may serve as a deputy/back-up Qualified Person for PV (QPPV), Local PV Contact, or Local Responsible PV Person as required by local PV legislation. If nominated as L-QPPV, commercial activities impacting L-QPPV are not permitted. In the absence of the Manager, the Sr. Specialist manages all day-to-day PV department activities and serves as back-up.

Required Education, Experience, and Skills

The candidate must hold a health, life science, or medical science degree or equivalent, be fluent in English (written and spoken), and proficient in the local language.

A minimum of 7 years of industry experience in pharmacovigilance is required.

Key competencies include advanced collaboration and partnering skills, strong communication skills, strategic thinking, project management, good business operations knowledge, and deep understanding of PV regulations and trends.

Additional Job Information

Must Haves:

• At least 5 years of PV experience
• Minimum 7 years of industry experience

Good to Haves:

• Experience in PV operations

Who We Are:

Organon delivers innovative health solutions to improve lives, focusing on women's health, biosimilars, and diverse health portfolios. Our vision is to create a better, healthier everyday life for every woman. We value diversity and inclusivity in our hiring practices.

Search Firm Policy:

Organon LLC does not accept unsolicited assistance from search firms without a valid agreement. All submissions without an agreement are the company's property, and no fees are paid for referrals without a pre-existing contract. Please refrain from contacting us directly regarding this matter.

Additional Details:

Salary ranges vary by country; this is a regular position with no relocation support. Travel, visa sponsorship, and other logistical details are specified in the full job posting. Requisition ID: R

The Senior Pharmacovigilance Specialist (Sr PV Specialist) reports to the PV Associate Director and is responsible for the daily case management activities for assigned country(ies).

The PV Senior Specialist handles all PV activities, including aggregate and individual case safety report (ICSR) submissions to health authorities, compliance monitoring, and may serve as the PV contact with local stakeholders, headquarters (HQ), and local health authorities. The role involves collaborating with colleagues to ensure compliance with local laws and regulations, backing up colleagues, and adjusting schedules to prevent gaps in adverse event reporting and safety oversight.

Additional responsibilities (delegated/assigned by the Manager) may include PV intake, negotiation of local PV agreements, due diligence activities, audits and inspections, review of local initiatives for PV compliance, SOP management, local training, communication of safety issues, people development, and special projects, often working independently.

The Sr. Specialist may serve as a deputy/back-up Qualified Person for PV (QPPV), Local PV Contact, or Local Responsible PV Person as required by local PV legislation. If nominated as L-QPPV, commercial activities impacting L-QPPV are not permitted. In the absence of the Manager, the Sr. Specialist manages all day-to-day PV department activities and serves as back-up.

Required Education, Experience, and Skills

The candidate must hold a health, life science, or medical science degree or equivalent, be fluent in English (written and spoken), and proficient in the local language.

A minimum of 7 years of industry experience in pharmacovigilance is required.

Key competencies include advanced collaboration and partnering skills, strong communication skills, strategic thinking, project management, good business operations knowledge, and deep understanding of PV regulations and trends.

Additional Job Information

Must Haves:

• At least 5 years of PV experience
• Minimum 7 years of industry experience

Good to Haves:

• Experience in PV operations

Who We Are:

Organon delivers innovative health solutions to improve lives, focusing on women's health, biosimilars, and diverse health portfolios. Our vision is to create a better, healthier everyday life for every woman. We value diversity and inclusivity in our hiring practices.

Search Firm Policy:

Organon LLC does not accept unsolicited assistance from search firms without a valid agreement. All submissions without an agreement are the company's property, and no fees are paid for referrals without a pre-existing contract. Please refrain from contacting us directly regarding this matter.

Additional Details:

Salary ranges vary by country;

this is a regularposition with no relocation support. Travel, visa sponsorship, and other logistical details are specified in the full job posting. Requisition ID: R

The Senior Pharmacovigilance Specialist (Sr PV Specialist) reports to the PV Associate Director and is responsible for the daily case management activities for assigned country(ies).

The PV Senior Specialist handles all PV activities, including aggregate and individual case safety report (ICSR) submissions to health authorities, compliance monitoring, and may serve as the PV contact with local stakeholders, headquarters (HQ), and local health authorities. The role involves collaborating with colleagues to ensure compliance with local laws and regulations, backing up colleagues, and adjusting schedules to prevent gaps in adverse event reporting and safety oversight.

Additional responsibilities (delegated/assigned by the Manager) may include PV intake, negotiation of local PV agreements, due diligence activities, audits and inspections, review of local initiatives for PV compliance, SOP management, local training, communication of safety issues, people development, and special projects, often working independently.

The Sr. Specialist may serve as a deputy/back-up Qualified Person for PV (QPPV), Local PV Contact, or Local Responsible PV Person as required by local PV legislation. If nominated as L-QPPV, commercial activities impacting L-QPPV are not permitted. In the absence of the Manager, the Sr. Specialist manages all day-to-day PV department activities and serves as back-up.

Required Education, Experience, and Skills

The candidate must hold a health, life science, or medical science degree or equivalent, be fluent in English (written and spoken), and proficient in the local language.

A minimum of 7 years of industry experience in pharmacovigilance is required.

Key competencies include advanced collaboration and partnering skills, strong communication skills, strategic thinking, project management, good business operations knowledge, and deep understanding of PV regulations and trends.

Additional Job Information

Must Haves:

• At least 5 years of PV experience
• Minimum 7 years of industry experience

Good to Haves:

• Experience in PV operations

Who We Are:

Organon delivers innovative health solutions to improve lives, focusing on women's health, biosimilars, and diverse health portfolios. Our vision is to create a better, healthier everyday life for every woman. We value diversity and inclusivity in our hiring practices.

Search Firm Policy:

Organon LLC does not accept unsolicited assistance from search firms without a valid agreement. All submissions without an agreement are the company's property, and no fees are paid for referrals without a pre-existing contract. Please refrain from contacting us directly regarding this matter.

Additional Details:

Salary ranges vary by country; this is a regular position with no relocation support. Travel, visa sponsorship, and other logistical details are specified in the full job posting. Requisition ID: R

TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and Functional Service (FSP) solutions.

Join Our Team as a SeniorDrug Safety Manager , dedicated to our global Ophthalmology business unit.

About this role

As part of our Ophthalmology focussed Drug Safety Manager team you will working alongside passionate and innovative professionals to ensure our customers achieve their goals.

Key Responsibilities

• Pharmacovigilance Oversight : Manage SAE handling in clinical trials and post-marketing, ensuring compliance with SOPs and regulatory requirements; review and approve safety cases, coding, and reconciliation.
• Leadership & Project Management : Lead safety-only projects and cross-functional initiatives; oversee departmental safety activities and ensure project execution aligns with legal and procedural standards.
• Process & Quality Management : Develop and maintain SOPs, templates, and safety processes; implement new procedures and validate safety-related systems.
• Regulatory Compliance : Stay updated on global pharmacovigilance regulations and ensure adherence across all safety operations.
• People Management : Line manage Drug Safety Unit staff, including coaching, mentoring, performance reviews, salary negotiations, and onboarding / training of new personnel.
• Administrative Duties : Approve time reports, travel expenses, and manage invoicing / revenue for assigned projects.

Qualifications

What We Offer

We provide a competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment. You’ll be joining a team that values collaboration, innovation, and making a difference in the lives of patients

A Bit More About Us

Our journey began over 25 years ago in Sweden, in the city of Lund. As a global CRO with the ultimate goal of ensuring patients’ safety and well-being, we provide biotechnology and pharmaceutical companies with tailored clinical development solutions. We currently operate in 17 countries across Europe, North America, Asia Pacific and the Middle East.

Our core values of Trust, Quality, Flexibility and Passion are what make TFS Healthscience the successful company it is today. Our values shape our culture and work ethic. They reflect what we stand for and guide our organization.

Together we make a difference

TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and Functional Service (FSP) solutions.

Join Our Team as a SeniorDrug Safety Manager, dedicated to our global Ophthalmology business unit.

About this role

As part of our Ophthalmology focussed Drug Safety Manager team you will working alongside passionate and innovative professionals to ensure our customers achieve their goals.

Key Responsibilities

• Pharmacovigilance Oversight : Manage SAE handling in clinical trials and post-marketing, ensuring compliance with SOPs and regulatory requirements;
  
  review and approve safety cases, coding, and reconciliation.
• Leadership & Project Management : Lead safety-only projects and cross-functional initiatives;
  
  oversee departmental safety activities and ensure project execution aligns with legal and procedural standards.
• Process & Quality Management : Develop and maintain SOPs, templates, and safety processes;
  
  implement new procedures and validate safety-related systems.
• Regulatory Compliance : Stay updated on global pharmacovigilance regulations and ensure adherence across all safety operations.
• People Management : Line manage Drug Safety Unit staff, including coaching, mentoring, performance reviews, salary negotiations, and onboarding / training of new personnel.
• Administrative Duties : Approve time reports, travel expenses, and manage invoicing / revenue for assigned projects.

Qualifications

• Extensive and proven Drug Safety Background.
• Adaptability & Independence : Thrive in fast-paced environments with shifting priorities;
  
  capable of working autonomously or within a matrix team structure.
• Scientific & Regulatory Knowledge : Strong grasp of medical terminology, therapeutic areas, GCP, ICH guidelines, pharmacovigilance legislation, and internal SOPs.
• Communication Skills : Excellent written and verbal communication, with the ability to clearly convey complex safety information.
• Technical Proficiency : Skilled in word processing;
  
  proficient with spreadsheets;
  
  presentation software experience is a plus.
• Leadership & Mentorship : Proven ability to lead, mentor, educate, and supervise Drug Safety personnel.
• Analytical Thinking : Demonstrates sound judgment and critical thinking in safety-related decision-making.

What We Offer

We provide a competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment. You’ll be joining a team that values collaboration, innovation, and making a difference in the lives of patients

A Bit More About Us

Our journey began over 25 years ago in Sweden, in the city of Lund. As a global CRO with the ultimate goal of ensuring patients’ safety and well-being, we provide biotechnology and pharmaceutical companies with tailored clinical development solutions. We currently operate in 17 countries across Europe, North America, Asia Pacific and the Middle East.

Our core values of Trust, Quality, Flexibility and Passion are what make TFS Healthscience the successful company it is today. Our values shape our culture and work ethic. They reflect what we stand for and guide our organization.

Together we make a difference

TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and Functional Service (FSP) solutions.

Join Our Team as a SeniorDrug Safety Manager , dedicated to our global Ophthalmology business unit.

About this role

As part of our Ophthalmology focussed Drug Safety Manager team you will working alongside passionate and innovative professionals to ensure our customers achieve their goals.

Key Responsibilities

• Pharmacovigilance Oversight : Manage SAE handling in clinical trials and post-marketing, ensuring compliance with SOPs and regulatory requirements; review and approve safety cases, coding, and reconciliation.
• Leadership & Project Management : Lead safety-only projects and cross-functional initiatives; oversee departmental safety activities and ensure project execution aligns with legal and procedural standards.
• Process & Quality Management : Develop and maintain SOPs, templates, and safety processes; implement new procedures and validate safety-related systems.
• Regulatory Compliance : Stay updated on global pharmacovigilance regulations and ensure adherence across all safety operations.
• People Management : Line manage Drug Safety Unit staff, including coaching, mentoring, performance reviews, salary negotiations, and onboarding / training of new personnel.
• Administrative Duties : Approve time reports, travel expenses, and manage invoicing / revenue for assigned projects.

Qualifications

What We Offer

We provide a competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment. You’ll be joining a team that values collaboration, innovation, and making a difference in the lives of patients

A Bit More About Us

Our journey began over 25 years ago in Sweden, in the city of Lund. As a global CRO with the ultimate goal of ensuring patients’ safety and well-being, we provide biotechnology and pharmaceutical companies with tailored clinical development solutions. We currently operate in 17 countries across Europe, North America, Asia Pacific and the Middle East.

Our core values of Trust, Quality, Flexibility and Passion are what make TFS Healthscience the successful company it is today. Our values shape our culture and work ethic. They reflect what we stand for and guide our organization.

Together we make a difference