Takeda
Overview
Medical Director Pharmacovigilance, Rare Disease & PDT role at Takeda. This position leads product safety strategy and global safety oversight for assigned pharmaceutical/biological/medical device products.
Responsibilities
- Serve as Global Safety Lead, oversee safety strategy and deliverables for each assigned product.
- Lead GPSE Safety Team and Safety Management Team for assigned compounds and products.
- Analyze and interpret safety data from non‑clinical, clinical, post‑marketing and scientific literature to assess benefit‑risk profiles.
- Conduct signal detection, monitoring, evaluation and management for assigned products.
- Develop and lead preparation of responses to safety‑related inquiries from regulatory agencies, ethics committees and other stakeholders.
- Provide medical safety expertise and authorship for critical documents (protocols, INDs, NDAs, BLAs, CTAs, safety reports, etc.).
- Provide patient safety input to the clinical development program and represent GPSE on internal governance bodies.
- Collaborate with Clinical Development, Regulatory Affairs, Quality Assurance, Medical Affairs, Marketing, Manufacturing, and Legal.
- Ensure up‑to‑date representation of safety information in labeling documents and Company Core Data Sheets.
- Travel to the U.S. up to 10% for internal meetings; remote work 100% permitted.
Qualifications
- Doctor of Medicine (M.D.) and a minimum of 5 years of related experience.
- Experience utilizing Oracle Empirica for routine signal detection, trend analysis and safety signal identification.
- Proficiency in statistical methods for safety data analysis, including disproportionality analysis.
- Knowledge of MedDRA and WHO Drug Dictionary coding for adverse event reporting.
- Experience developing risk management plans, periodic safety reports, and safety‑related regulatory documents.
- Strong communication skills and ability to train and mentor Pharmacovigilance associates and specialists.
Compensation
$228,200.00/yr – $358,600.00/yr
Location
Cambridge, MA (U.S.)
EEO & Legal
Qualified applicants can apply at Please reference job #R . EOE.
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