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Job Description
BridgeBio is seeking a Senior Medical Director to lead the international safety strategy for assigned products. The Senior Medical Director will be responsible for comprehensive oversight and strategic oversight of core safety information and local labeling, postmarketing safety data review, benefit-risk assessment, risk management, and be a subject matter expert during agency inspections. This role involves collaborating with Clinical Operations, QA, Clinical Research, Regulatory Affairs, and Medical Writing to determine safety strategy for all international expansion markets.
Role Involves:
- Managing medical adverse event and aggregate safety data related to international markets.
- Hosting and performing pharmacovigilance safety audits across assigned international partner organisations and markets.
- Establishing the safety strategy for postmarketing safety, core safety information, local labeling, safety reporting, benefit-risk evaluation, risk management, engagement with regulatory authorities, and authoring of responses to inquiries.
- Co-managing the PV agreements and compliance of all assigned local distribution organizations and for compliance tracking for all safety submissions across all drug safety functions of the local distribution organizations.
- Developing and presenting assessments of safety data, safety signals, benefit and risk for internal senior management as well as external partner or regulatory authorities.
Requirements:
- Medical Degree
- At least 12 years of drug safety and pharmacovigilance experience
- Extensive experience with Regulatory submissions for NDAs, EU MAAs, and other countries’ Regulatory reviews; experience in Canada, Brazil and Australia preferred
- FDA and EMA, but also other regulatory bodies (e.g. Anvisa, Health Canada...) inspection experience for new approvals
- Extensive experience with all aspects safety signal evaluation
- Extensive experience in both clinical development and post-marketing safety
- Demonstrated ability to successfully manage drug safety team or drug safety CSO for a postmarketing program with responsibilities for expedited reporting, on-time PBRER preparation
- Intimate knowledge of GCP and strong working knowledge of FDA, Good Clinical Practices, and ICH regulations and guidelines
What BridgeBio Offers:
- Patient Days
- A culture inspired by our values
- Access to learning and development resources
- Robust and market-competitive compensation & benefits package
- Commitment to Diversity, Equity & Inclusion
