Remote Medical Director, Pharmacovigilance & Rare Disease

Takeda Pharmaceutical Co.; Boston (MA); Remote; USD 302.000 - 373.000; Vollzeit

Zusammenfassung

Takeda Development Center Americas, Inc. seeks a Medical Director Pharmacovigilance, Rare Disease & PDT to lead safety strategy and serve as the Global Safety Lead for assigned products.

You will collaborate with Clinical Development, Regulatory Affairs, Medical Affairs, and cross-functional teams to manage safety data, perform signal detection, and prepare safety documents. Up to 100% remote work is allowed.

Qualifikationen

• Doctor of Medicine degree and 5 years of related experience.
• Experience with pharmacovigilance signal detection in multiple data sources.
• Ability to interpret safety data to inform benefit-risk assessments.
• Experience writing safety documentation (RMPs, ICH reports, IBs).

Aufgaben

• Serve as Global Safety Lead (GSL) and company-wide patient safety expert for assigned products.
• Lead GPSE Safety Team (GST) and Safety Management Team (SMT); represent product safety in governance bodies.
• Analyze safety data from clinical and post-marketing sources to assess benefit-risk and update safety documents.
• Develop risk-management strategies and respond to safety inquiries from regulators and ethics committees.

Kenntnisse

Signal detection

Safety data analysis

Regulatory liaison

Clinical pharmacovigilance

Ausbildung

Doctor of Medicine

Tools

Oracle Empirica

MedDRA

WHO DD dictionary

Jobbeschreibung

Takeda Development Center Americas, Inc. seeks a Medical Director Pharmacovigilance, Rare Disease & PDT to lead safety strategy and serve as the Global Safety Lead for assigned products.

You will collaborate with Clinical Development, Regulatory Affairs, Medical Affairs, and cross-functional teams to manage safety data, perform signal detection, and prepare safety documents. Up to 100% remote work is allowed.