Medical Director Pharmacovigilance, Rare Disease & PDT
Takeda
1 month ago
Remote
United States
$237,200 - $372,790 USD yearly
Medical Affairs
JOB LOCATION: Cambridge, MA
POSITION: Medical Director Pharmacovigilance, Rare Disease & PDT
POSITION RESPONSIBILITIES:
- Serve as Global Safety Lead (GSL) and company-wide patient safety expert for assigned pharmaceutical/biological/drug-device combination products; accountable for safety strategy and major safety deliverables for each product.
- Lead GPSE Safety Team (GST) and Safety Management Team (SMT) for assigned compounds/products; represent cross-functional program team as a product safety/risk mitigation expert for internal and external stakeholders.
- Analyze and interpret safety data (non-clinical, clinical, post-marketing, and scientific literature) to assess benefit-risk and update benefit-risk documents (e.g., RMPs).
- Conduct signal detection, monitoring, evaluation, interpretation, and management.
- Develop strategy and lead responses to safety-related inquiries from regulatory agencies and ethics committees (MAAs, NDAs, BLAs).
- Provide medical safety expertise and author/review critical documents (protocols/amendments, ICFs, IBs, IMPDs, clinical research reports, Health Hazard Evaluations, Signal Evaluation Reports, INDs, NDAs, BLAs, CTAs) with cross-functional colleagues.
- Provide patient safety input to clinical development programs and represent GPSE on internal governance bodies for relevant study documents.
- Collaborate with Clinical Development, Regulatory Affairs, Quality Assurance, Medical Affairs, Marketing, Manufacturing, and Legal on safety issues.
- Ensure up-to-date safety information in Company Core Data Sheet (incl. Reference Safety Information), Investigator Brochure, and other labeling documents.
- Up to 10% domestic travel; up to 100% remote work permitted.
REQUIREMENTS:
- Doctor of Medicine (M.D.) plus 5 years of related experience.
- Prior experience using Oracle Empirica for routine signal detection; analyze safety data to identify trends and detect new/emerging safety signals from spontaneous AERs, clinical trial data, and literature.
- Statistical analysis experience in Empirica (e.g., disproportionality analysis) to assess safety concerns and evaluate frequency/severity of adverse events.
- Experience developing risk management plans and risk minimization measures for drug/product safety concerns.
- Experience evaluating/developing periodic safety reports (e.g., Periodic Benefit Risk Evaluation Reports, Developmental Safety Update Reports, Periodic Adverse Drug Experience Reports).
- Proficiency using MedDRA and WHO DD dictionary coding for standardized adverse event and medicinal product information; medical review of adverse events for seriousness, expectedness, and causality.
- Experience designing/implementing development and training plans for pharmacovigilance associates/specialists, including performance review.
- Full time.
- Salary: $222,600 - $381,600 per year.
APPLICATION INSTRUCTIONS:
- Apply at https://jobs.takeda.com. Reference job #R0175791.
POSITION: Medical Director Pharmacovigilance, Rare Disease & PDT
POSITION RESPONSIBILITIES:
- Serve as Global Safety Lead (GSL) and company-wide patient safety expert for assigned pharmaceutical/biological/drug-device combination products; accountable for safety strategy and major safety deliverables for each product.
- Lead GPSE Safety Team (GST) and Safety Management Team (SMT) for assigned compounds/products; represent cross-functional program team as a product safety/risk mitigation expert for internal and external stakeholders.
- Analyze and interpret safety data (non-clinical, clinical, post-marketing, and scientific literature) to assess benefit-risk and update benefit-risk documents (e.g., RMPs).
- Conduct signal detection, monitoring, evaluation, interpretation, and management.
- Develop strategy and lead responses to safety-related inquiries from regulatory agencies and ethics committees (MAAs, NDAs, BLAs).
- Provide medical safety expertise and author/review critical documents (protocols/amendments, ICFs, IBs, IMPDs, clinical research reports, Health Hazard Evaluations, Signal Evaluation Reports, INDs, NDAs, BLAs, CTAs) with cross-functional colleagues.
- Provide patient safety input to clinical development programs and represent GPSE on internal governance bodies for relevant study documents.
- Collaborate with Clinical Development, Regulatory Affairs, Quality Assurance, Medical Affairs, Marketing, Manufacturing, and Legal on safety issues.
- Ensure up-to-date safety information in Company Core Data Sheet (incl. Reference Safety Information), Investigator Brochure, and other labeling documents.
- Up to 10% domestic travel; up to 100% remote work permitted.
REQUIREMENTS:
- Doctor of Medicine (M.D.) plus 5 years of related experience.
- Prior experience using Oracle Empirica for routine signal detection; analyze safety data to identify trends and detect new/emerging safety signals from spontaneous AERs, clinical trial data, and literature.
- Statistical analysis experience in Empirica (e.g., disproportionality analysis) to assess safety concerns and evaluate frequency/severity of adverse events.
- Experience developing risk management plans and risk minimization measures for drug/product safety concerns.
- Experience evaluating/developing periodic safety reports (e.g., Periodic Benefit Risk Evaluation Reports, Developmental Safety Update Reports, Periodic Adverse Drug Experience Reports).
- Proficiency using MedDRA and WHO DD dictionary coding for standardized adverse event and medicinal product information; medical review of adverse events for seriousness, expectedness, and causality.
- Experience designing/implementing development and training plans for pharmacovigilance associates/specialists, including performance review.
- Full time.
- Salary: $222,600 - $381,600 per year.
APPLICATION INSTRUCTIONS:
- Apply at https://jobs.takeda.com. Reference job #R0175791.