Medical Director, Pharmacovigilance

Takeda Pharmaceutical; Warszawa; Hybrid; PLN 550,000 - 900,000; Full time

Job summary

Takeda Pharmaceutical Co. in Warsaw, Poland, is seeking a Medical Director for Global Patient Safety to lead the safety strategy and expert oversight for assigned medicines. This physician-led role combines clinical judgement with rigorous safety analysis and cross-functional collaboration to protect patients across the lifecycle.

You will mentor PV physicians, interact with health authorities, and contribute to regulatory submissions while ensuring clear safety communications across teams.

Qualifications

• MD, DO or international medical equivalent with active licensure.
• Minimum 5 years in pharma Pharmacovigilance/Drug Safety.
• At least 3 years in aggregate reporting, safety surveillance, signal management, or risk management.
• Strong analytical ability to evaluate safety data at a population level.
• Knowledge of national and international pharmacovigilance/regulatory requirements.
• Experience translating complex medical information into actionable risk management strategies.

Responsibilities

• Lead Global Safety teams and Safety Management Teams for assigned products.
• Analyse safety information from clinical, non-clinical, post-marketing, and literature sources.
• Lead signal detection, evaluation, monitoring and signal management.
• Own and communicate evolving benefit-risk profile of medicines.
• Provide medical interpretation of emerging safety information to senior stakeholders.
• Develop strategies for safety-related inquiries from regulators and ethics committees.
• Contribute to regulatory documents (protocols, IBs, ICFs, INDs, NDAs, BLAs, CTAs).
• Mentor Pharmacovigilance physicians and specialists.

Skills

Analytical thinking

Cross-functional collaboration

Scientific communication

Regulatory understanding

Education

MD, DO or internationally recognised medical equivalent

Master of Public Health (MPH)

Job description

Job Description

Medical Director, Pharmacovigilance / Global Patient Safety

Location: Warsaw, Poland | Hybrid

The opportunity

Are you a physician with pharmaceutical industry experience in pharmacovigilance or drug safety who wants to influence patient safety at a global level?

We are looking for a Medical Director to join our Global Patient Safety organization and take a leading role in evaluating, understanding and managing the safety profile of important medicines.

This is a role for a physician who enjoys looking beyond the individual patient to understand safety at a broader population level. You will bring together clinical judgement, scientific evidence and quantitative analysis to identify and evaluate safety signals, understand benefit-risk and help determine the appropriate safety strategy for assigned products.

What you will do

As Medical Director, you will serve as the Global Safety Lead (GSL)and company-wide patient safety expert for assigned pharmaceutical, biological and/or drug-device combination products. You will have accountability for the safety strategy and major safety deliverables associated with your products.

You will:

• Lead Global Patient Safety teams and Safety Management Teams for assigned compounds and products.
• Analyse and interpret safety information from clinical, non-clinical, post-marketing and scientific literature sources.
• Lead signal detection, evaluation, monitoring, interpretation and ongoing signal management.
• Own and communicate the evolving benefit-risk profile of assigned medicines.
• Provide medical and scientific interpretation of emerging safety information and ensure significant findings are communicated appropriately to senior stakeholders.
• Develop strategies and responses to safety-related enquiries from regulatory authorities and ethics committees.
• Provide medical safety expertise across key regulatory and clinical documents, including protocols, Investigator Brochures, informed consent forms, IMPDs, clinical study reports, INDs, NDAs, BLAs and CTAs.
• Contribute patient-safety expertise to clinical development programmes and internal governance discussions.
• Author and maintain benefit-risk and risk-management documentation, including RMPs.
• Ensure safety information is appropriately represented within Company Core Data Sheets, Reference Safety Information, Investigator Brochures and other labelling documentation.
• Partner closely with colleagues across Clinical Development, Regulatory Affairs, Quality, Medical Affairs, Manufacturing, Marketing and Legal.
• Interact with health authorities as part of cross-functional teams supporting regulatory submissions and responses.
• Mentor and support the development of Pharmacovigilance Physicians and Specialists.

What you bring

This is first and foremost a physician-led pharmacovigilance role. We are looking for someone who can combine medical judgement with rigorous analysis of safety information across patient populations.

Essential experience and qualifications

• MD, DO or internationally recognised medical equivalent, with direct clinical experience in patient care following postgraduate medical training. Board certification and medical licensure are preferred.
• At least 5 years of pharmaceutical-industry experience within Drug Safety/Pharmacovigilance, including experience with both investigational and marketed products.
• At least 3 years' experience across areas such as aggregate reporting, safety surveillance, signal management and/or risk management.
• Strong analytical capability and the ability to evaluate safety information at a population level rather than solely through individual patient cases.
• Knowledge and understanding of national and international pharmacovigilance and regulatory requirements.
• Experience working cross-functionally and translating complex medical and safety information into clear recommendations and risk-management strategies.

An advantage, but not essential

• Quantitative research or academic research experience.
• A Master of Public Health (MPH) or comparable background that has developed population-level research and analytical capabilities.
• Previous experience acting as a Drug Safety Physician, Safety Lead, Global Safety Lead or Medical Director within pharmacovigilance.

What will make you successful

You are likely to thrive in this position if you:

• Combine strong clinical judgement with an analytical and evidence-driven approach.
• Are comfortable interpreting complex safety datasets and identifying the medical significance behind the data.
• Can move between detailed scientific assessment and broader strategic benefit-risk decisions.
• Communicate confidently with senior internal stakeholders and health authorities.
• Enjoy working across functions and geographies.
• Are motivated by making decisions that ultimately protect patients across the lifecycle of a medicine.

The role may require local and international travel across Takeda sites.

Locations

Warsaw, Poland

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time