Medical Director Pharmacovigilance, Rare Disease & PDT

Role: Medical Director Pharmacovigilance for Rare Disease & PDT at Takeda, serving as Global Safety Lead and patient safety expert for assigned products. Responsibilities: oversee safety strategy, lead safety teams (GPSE Safety Team and Safety Management Team), analyze safety data from clinical, non-clinical, and post-marketing sources, conduct signal detection, evaluate benefit-risk profiles, develop responses to regulatory safety inquiries, review and author safety-related documentation, and ensure safety information is accurately updated in regulatory documents. Collaborate across functions including Clinical Development, Regulatory, Medical Affairs, and Quality Assurance. Requirements: MD with 5+ years’ experience, proficient in Oracle Empirica for signal detection, safety data analysis, MedDRA coding, and risk management planning; strong knowledge of pharmacovigilance activities related to biologics or pharmaceuticals, with experience in safety reporting, benefit-risk assessments, and regulatory submissions. High-Value: biologics or drug-device combination products, post-marketing and clinical safety data, signal detection, risk mitigation, and regulatory response. Work Setup: remote work up to 100%, domestic travel up to 10%, based in Boston, MA.