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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.
Locations
Warsaw, Poland
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time