Medical Director - Patient Safety and Pharmacovigilance (PSPV)
Takeda · Warsaw · PLN 421,400–PLN 579,480 (stated in the posting)
Job Description
Objective:
Provide strategic and medical leadership for global patient safety across assigned products within the MPMD portfolio. Act as the Global Safety Lead (GSL), accountable for end-to-end safety strategy, benefit-risk evaluation, and delivery of high-quality, regulator-ready safety outputs that support development and lifecycle management.
Principal responsibilities include:
- Serve as Global Safety Lead (GSL) and the Company-wide subject matter expert in patient for assigned pharmaceutical, biological, drug-device combination products. Accountable for defining and executing the safety strategy and for delivering major safety outputs across the product lifecycle.
- Lead PSPV Global Safety Team (GST) and Safety Management Team (SMT), ensuring alignment on safety priorities, timely decision-making, and clear accountability across functions.
- Represent the cross-functional program team as a product safety profile and risk mitigation expert for internal (e.g., Takeda Safety Board) and external (e.g., Independent Data Monitoring Committee, regulatory agencies).
- Manage cross-functional assessment of benefit-risk profile and ensure consistent, accurate, and timely communication of safety information to internal and external stakeholders.
- Provide proactive, science-based guidance on emerging safety issues and risk minimization strategies, ensuring early identification and mitigation of potential risks.
Accountabilities:
- Analyze and interpret safety data from various sources including non-clinical, clinical, post-marketing real-world evidence, and scientific literature.
- Conduct signal detection, monitoring, evaluation, interpretation, and management, ensuring compliance with global regulatory expectations and internal procedures.
- Develop strategy for and lead preparation of responses to safety-related inquiries from regulatory agencies and ethics committees, ensuring responses are scientifically robust, consistent, and inspection-ready.
- Ensure communication of all safety information that may impact the benefit-risk profile of assigned products to senior management and governance bodies.
- Provide medical safety expertise, medical interpretation, review, and authorship of appropriate sections for critical documents (e.g., protocols and amendments, informed consent forms (ICFs), investigator brochures (IBs), IMPDs, clinical studies reports (CSR), Health Hazard Evaluations (HHE), Signal Evaluation Reports (SER), INDs, NDAs, BLAs, and CTAs) in collaboration with cross-functional colleagues.
- Integrate safety considerations into clinical development program for assigned products and development compounds, including input into study design, statistical analysis plans, and key endpoints to ensure appropriate safety characterization.
- Manage benefit-risk profile, including authoring and maintaining regulatory documents such as Risk Management Plans (RMPs).
- Collaborate and with and influence cross-functional partners, including Clinical Development, Regulatory Affairs, Quality Assurance, Medical Affairs, Marketing, Manufacturing, and Legal, to ensure aligned and consistent safety messaging and decision-making.
- Interact with Regulatory Authorities as part of a cross-functional team to support submissions and effectively defend safety positions during regulatory interactions.
- Ensure up-to-date representation of safety information in Company Core Data Sheet (including Reference Safety Information) and Investigator Brochure, as well as other labeling documents.
- Demonstrate knowledge of regional and global pharmacovigilance regulations and evolving safety expectations.
- Support PSPV in maintaining a high-performing, inspection-ready global safety organization, ensuring full compliance with worldwide regulations and internal standards.
- Train, mentor, and provide scientific guidance to Pharmacovigilance Physicians and Safety Scientists, helping to build capability and ensure consistency of safety assessments.
- Maintain professional knowledge and accreditation by active participation in continuing medical education activities and contribute to a culture of continuous learning and scientific.
- Preferred to have capability in leveraging quantitative methodologies and emerging technologies, including artificial intelligence, to enhance signal detection and safety surveillance, while ensuring scientific validity and regulatory acceptability.
Qualifications:
- M.D. or D.O. or internationally recognized equivalent, with relevant clinical experience following post-graduate training and appropriate grounding and knowledge of general medicine, epidemiology and biostatistics. Board certification and licensure preferred.
- A minimum of 5 years of experience in Drug Safety/Pharmacovigilance, including ≥3 years in post-marketing safety, with demonstrated expertise in aggregate reporting, safety surveillance, signal management, safety labeling, benefit-risk assessment and risk management is required.
- Knowledge and understanding of national and international PV and regulatory guidelines (e.g., FDA, EMA, PMDA, ICH guidelines).
- Experience in responding to safety-related inquiries of various regulatory authorities.
- Strong scientific judgment and ability to make decisions in the context of uncertainty and incomplete data.
- Excellent verbal and written communication skills, with strong interpersonal abilities to effectively engage cross-functional stakeholders and operate in high-visibility, high-stakes governance environments.
- Demonstrated ability to influence without authority and drive alignment across global, matrixed teams.
Travel Requirements: Local and international travel across Takeda sites may be required based on business needs.
Work arrangement: Hybrid in accordance with Takeda’s Hybrid and Remote Work policy. Flexibility to support US Eastern Time zone activities may be required occasionally to enable effective global collaboration and urgent regulatory responses.
Diversity, Equity & Inclusion
At Takeda, we are committed to fostering a diverse, equitable, and inclusive environment where every individual can thrive. We believe that diversity of backgrounds, perspectives, and experiences drives innovation and strengthens our ability to deliver for patients.
We welcome applications from all qualified candidates and are dedicated to creating an inclusive workplace where everyone feels valued, respected, and empowered to achieve their full potential.
More About Us
Takeda is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to advancing innovative medicines across gastroenterology, rare diseases, plasma-derived therapies, oncology, neuroscience, and vaccines.
Locations
Warsaw, Poland
Base Salary Range:
zł421,400.00 - zł579,480.00
For information about our benefits, please click here.