Medical Director, Pharmacovigilance

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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.

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About Us

Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own.

Takeda is an equal opportunity employer.

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