Medical Director Pharmacovigilance, Rare Disease & PDT
Takeda
Summary
Takeda Development Center Americas, Inc. is seeking a Medical Director Pharmacovigilance, Rare Disease & PDT to serve as Global Safety Lead (GSL) and the Company-wide patient safety expert for assigned pharmaceutical / biological / drug-device combined products, accountable for the safety strategy and major safety deliverables for each assigned product.
Job description
- Lead GPSE Safety Team (GST) and Safety Management Team (SMT) for assigned compounds and products and represent the cross-functional program team as a product safety profile and risk mitigation expert for internal and external stakeholders.
- Analyze and interpret safety data from various sources including non-clinical, clinical, post-marketing and scientific literature for assessment of benefit-risk profile and updating of benefit-risk documents, e.g., RMPs.
- Conduct signal detection, monitoring, evaluation, interpretation, and management for assigned compounds and products.
- Develop strategy for and lead preparation of responses to safety-related inquiries from regulatory agencies and ethics committees, MAAs, NDAs, and BLAs.
- Provide medical safety expertise, medical interpretation, review, and authorship of appropriate sections for critical documents (e.g., protocols and amendments, ICFs, IBs, IMPDs, clinical research reports, Health Hazard Evaluations, Signal Evaluation Reports, INDs, NDAs, BLAs, and CTAs) in collaboration with cross-functional colleagues.
- Provide patient safety input to the clinical development program for assigned products and development compounds, and represent GPSE on internal governance bodies for study protocols, statistical analysis plans and other clinical study-related documents as applicable.
- Collaborate and communicate safety issues with other functional areas such as Clinical Development, Regulatory Affairs, Quality Assurance, Medical Affairs, Marketing, Manufacturing, and Legal.
- Ensure up-to-date representation of safety information in Company Core Data Sheet (including Reference Safety Information) and Investigator Brochure, as well as other labeling documents.
Requirements
- Doctor of Medicine degree
- 5 years of related experience
- Utilize Oracle Empirica for routine signal detection activities and analyze safety data
- Identify trends and detect new or emerging safety signals from various data sources such as spontaneous adverse event reports (AERs), clinical trial data, and literature
- Analyze using statistical methodologies (e.g., disproportionality analysis) within Empirica to assess potential safety concerns and evaluate the frequency and severity of adverse events
- Analyze information to strategize, recommend, and develop risk management plans including risk minimization measures
- Evaluate and develop periodic safety reports including Periodic Benefit Risk Evaluation Reports, Developmental Safety Update Reports, and Periodic Adverse Drug Experience Reports
- Utilize MedDRA and assign appropriate MedDRA terms to describe adverse events
- WHO DD dictionary coding to accurately capture and standardize information related to medicinal products
- Medical review of all adverse event reports for seriousness, expectedness and causality
- Design and implementation of strategic, operational and personnel development plans as well as training curriculum for assigned Pharmacovigilance associates and specialists and their performance review
Benefits
- Medical, Dental & Vision
- 401(k)
- Paid time off
- Sick leave
- Company holidays
- Incentive compensation programs
Company overview
Takeda Pharmaceutical Company Limited is a Japanese multinational pharmaceutical company founded in 1781 and incorporated in 1925. As one of the world's top 20 largest pharmaceutical companies by revenue and the third largest in Asia, Takeda specializes in developing and commercializing innovative medicines across several therapeutic areas including oncology, rare diseases, neuroscience, gastroenterology, plasma-derived therapies, and vaccines. With approximately 49,095 employees globally, the company operates research and development centers, manufacturing facilities, and commercial operations across 39 U.S. states and numerous countries worldwide. Takeda maintains dual headquarters in Tokyo and Osaka, Japan, with significant operations in Cambridge, Massachusetts, where it serves as the largest life sciences employer in the state. The company's patient-focused approach is guided by its Takeda-ism values of Integrity, Fairness, Honesty, and Perseverance, emphasizing a commitment to delivering life-transforming treatments while advancing sustainable healthcare solutions. Takeda's extensive portfolio includes both innovative biologics and small molecule drugs, supported by strategic acquisitions and partnerships that have expanded its capabilities in areas such as immuno-oncology and rare disease treatments.