[Hiring] Medical Director Pharmacovigilance, Rare Disease & PDT @Takeda

Role 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.
• 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.
• 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.
• Provide medical safety expertise, medical interpretation, review, and authorship of appropriate sections for critical documents in collaboration with cross-functional colleagues.
• Provide patient safety input to the clinical development program for assigned products and development compounds.
• 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 and other labeling documents.
• Up to 10% domestic travel required to attend internal meetings.
• Up to 100% remote work allowed.

Qualifications

• Doctor of Medicine degree.
• 5 years of related experience.

Requirements

• 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, clinical trial data, and literature.
• Analyze using statistical methodologies (e.g., disproportionality analysis) within Empirica to assess potential safety concerns.
• Evaluate and develop risk management plans including risk minimization measures.
• Evaluate and develop periodic safety reports including Periodic Benefit Risk Evaluation Reports.
• Utilize MedDRA and assign appropriate MedDRA terms to describe adverse events.
• Design and implement strategic, operational, and personnel development plans for assigned Pharmacovigilance associates and specialists.

Benefits

• Medical, dental, and vision insurance.
• 401(k).
• Paid time off.
• Sick leave.
• Company holidays.
• Incentive compensation programs.
• Other benefits offered under company policies.