Medical Director, MPMD, PSPV
RemoteBengaluru, Karnataka, India
Job Summary
Provide strategic medical leadership for global patient safety across the MPMD portfolio as Global Safety Lead. Lead the PSPV GST/SMT, ensure alignment on safety priorities, and deliver regulator-ready safety outputs across the product lifecycle. Act as the medical safety SME for assigned products, integrate safety considerations into development programs, author/regulatory document input (e.g., RMPs, IRB/IB sections, CSR/ IMPD sections), and collaborate with Clinical Development, Regulatory Affairs, Quality Assurance, Medical Affairs, Manufacturing, Legal, and external stakeholders. Maintain up-to-date safety representations in core safety documents, support regulatory submissions and interactions, and mentor pharmacovigilance physicians and safety scientists. Travel as required; work arrangement: remote in accordance with Takeda’s hybrid/remote policy; flexibility to support US Eastern Time zone activities occasionally.
Required Qualifications
- M.D. or D.O. or internationally recognized equivalent with clinical experience, grounding in medicine, epidemiology and biostatistics
- Board certification and licensure preferred
- ≥5 years experience in Drug Safety/Pharmacovigilance, including ≥3 years post-marketing safety
- Experience in aggregate reporting, safety surveillance, signal management, safety labeling, benefit-risk assessment, risk management
- Knowledge of national and international PV/regulatory guidelines (FDA, EMA, PMDA, ICH)
- Experience in responding to safety-related regulatory inquiries
- Strong scientific judgment and decision-making under uncertainty
- Excellent verbal and written communication; ability to engage cross-functional stakeholders
- Ability to influence across global, matrixed teams
- Travel to local and international sites; remote work per policy
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