Medical Director Pharmacovigilance, Rare Disease & PDT

Overview

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Details

Job Location: Cambridge, MA

Position: Medical Director Pharmacovigilance, Rare Disease & PDT

Positions Description: Takeda Development Center Americas, Inc. is seeking a Medical Director Pharmacovigilance, Rare Disease & PDT with the following duties: 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; lead GPSE Safety Team (GST) and Safety Management Team (SMT) for assigned compounds and products and represents the cross functional program team as a product safety profile and risk mitigation expert for internal (e.g., Takeda Safety Board) and external (e.g., Independent Data Monitoring Committee) 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 the benefit-risk documents, e.g., RMPs, for assigned compounds and products; 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. Up to 10% domestic travel to attend internal meetings. Up to 100% remote work permitted.

Requirements

• Doctor of Medicine (M.D.) plus 5 years of related experience.
• Experience with Oracle Empirica for routine signal detection activities and analysis of safety data from data sources such as spontaneous adverse event reports, clinical trial data, and literature.
• Ability to analyze data using statistical methodologies (e.g., disproportionality analysis) within Empirica to assess potential safety concerns and evaluate frequency and severity of adverse events.
• Experience in developing risk management plans including risk minimization measures for safety concerns related to drugs in development or on the market.
• Experience evaluating and developing periodic safety reports (e.g., PSURs, Developmental Safety Update Reports, Periodic Adverse Drug Experience Reports).
• Experience utilizing MedDRA and WHO DD dictionary coding and performing medical review of adverse event reports for seriousness, expectedness, and causality.
• Ability to design and implement strategic, operational and personnel development plans and training curricula for Pharmacovigilance staff.

Additional Details

• Full time.
• Salary: $222,600 - $381,600 per year.
• Qualified applicants can apply at Please reference job #R . EOE
• Locations: Boston, MA
• Worker Type: Employee
• Worker Sub-Type: Regular
• Time Type: Full time

#J-18808-Ljbffr