Medical Director, Pharmacovigilance

Takeda; Województwo mazowieckie; Hybrid; PLN 320,000 - 540,000; Full time

Job summary

Takeda in Warsaw, Poland is seeking a Medical Director to join our Global Patient Safety organization. You will lead safety strategy for assigned medicines and evaluate safety data across clinical, non-clinical, and post-marketing sources.

This physician-led role requires translating medical insights into risk-management strategies, leading cross-functional teams, and communicating with regulators and senior stakeholders while supporting regulatory submissions.

Qualifications

• MD/DO or equivalent with clinical care experience after training.
• At least 5 years in pharma, Drug Safety/Pharmacovigilance.
• At least 3 years in aggregate reporting, safety surveillance, or risk management.
• Strong ability to interpret safety data at population level.
• Familiarity with regulatory requirements in pharmacovigilance.

Responsibilities

• Lead Global Patient Safety teams and Safety Management Teams for assigned products.
• Analyse and interpret safety information from clinical, non-clinical, post-marketing and 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 to senior stakeholders.
• Develop strategies and responses to regulatory inquiries.
• Provide medical safety expertise across regulatory documents (ICH/CTAs/RSI).
• Contribute to clinical development programmes and governance discussions.
• Author and maintain risk-management documentation including RMPs.
• Ensure safety information is represented in core labeling and safety documents.
• Partner with colleagues across Clinical Development, Regulatory Affairs, Quality, Medical Affairs, Manufacturing, Marketing and Legal.
• Interact with health authorities during regulatory submissions and responses.
• Mentor and support the development of Pharmacovigilance Physicians and Specialists.

Skills

Pharmacovigilance experience

Analytical capability

Cross-functional collaboration

Regulatory knowledge

Communication with senior stakeholders

Education

MD/DO or internationally recognised medical equivalent

Board certification and medical licensure (preferred)

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