Senior Medical Director, Drug Safety and Pharmacovigilance

Summary

Join BridgeBio as a Senior Medical Director and lead the international safety strategy for assigned products. Collaborate with colleagues to bring safe, new treatments to patients. Provide comprehensive oversight of core safety information, postmarketing safety data, benefit-risk assessment, and risk management. Serve as a subject matter expert during agency inspections and manage all aspects of medical adverse events and aggregate safety data. Work with various teams to determine safety strategies for international markets and provide medical safety input for submissions and regulatory queries. Travel is required.

Requirements

• Medical Degree
• Requires at least 12 years of drug safety and pharmacovigilance experience (clinical trials safety experience in the biotechnology, pharmaceutical, drug safety contract service organization (CSO)) with at least 3 years of oversight management experience (line management or CSO management)
• 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
• Growing a clinical trial drug safety system into a global post-marketing PV system
• Extensive experience with all aspects safety signal evaluation, including review and analysis of data, collaboration with cross functional team members and senior management, authoring of required regulatory correspondence, and safety label updates
• 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
• Extensive experience in leading drug safety audits and acting as lead SME for global agency inspections
• Extensive experience with managing internal and partner compliance with Pharmacovigilance Agreements and Safety Data Exchange Agreements
• Intimate knowledge of GCP and strong working knowledge of FDA, Good Clinical Practices, and ICH regulations and guidelines
• Proven ability to collaborate successfully with postmarketing teams, including medical affairs, biostats, regulatory, medical writing, and QA
• Experience in managing all postmarketing safety aspects of product quality defect investigations and assessments
• Management of compliance deviations and formulation of CAPAs
• Familiar with clinical trial safety database use and CIOMS II and PBRER reporting generation (Argus, ArisG, or VeevaSafety) and Microsoft Office Suite required (Word, Excel, PowerPoint, Project, Outlook)
• Intimate knowledge of GCP and strong working knowledge of FDA or other agencies, EU Good Clinical Practices, and ICH regulations and guidelines
• Must be able and willing to travel periodically for face-to-face engagements with regulatory authorities, and occasional on site meetings (if based remotely)

Responsibilities

• Lead the international safety strategy for your assigned products, working closely with highly motivated colleagues eager to bring safe, new treatments to patients
• Provide 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
• Manage all aspects of the medical adverse event and aggregate safety data related to the international markets and the BridgeBio partner organisations and will be an integral member of the Safety Management Team
• Collaborate with Clinical Operations, QA, Clinical Research, Regulatory Affairs, and Medical Writing to determine safety strategy for all international expansion markets
• Provide medical safety/pharmacovigilance input and oversight of all international market submissions and related Regulatory queries
• The Senior Medical Director is responsible for the overall risk management and safety strategy of assigned products, including both internal and external engagement with key collaborators
• The Senior Medical Director is expected to be the international medical safety expert for assigned products, independently write safety sections of international marketing applications, independently reply to agency requests, and represent BridgeBio on the international regulatory stage by meeting with and presenting to Regulatory Authorities during meetings and inspections (preapproval, pharmacovigilance, and ad hoc)
• Travel is required
• Oversight and understanding of all aspects of the assigned product’s safety profile from clinical development to post-approval safety surveillance, including management of contract service organizations and partners that provide safety data
• Hosts and performs pharmacovigilance safety audits across assigned international partner organisations and markets
• Ensures compliance with pharmacovigilance regulatory requirements across assigned international partner organisations and markets
• Present data to the Safety Management Committee for designated product(s), and be responsible for identifying any emerging safety trends, defining the safety profile, and recommending safety actions based upon cumulative safety data
• In collaboration with regulatory, clinical development, medical affairs, and business partners, establish 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-manages 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
• Co-manages ongoing reconciliation of incoming safety information and the safety databases
• Acts as co-liaison with external collaborators to develop processes to meet regulatory reporting requirements
• Participate in publication preparation and medical information material review
• Manage medical aspects of aggregate data analysis, presentation of medical analyses internally and to regulatory agencies as required, expedited case analyses, scientifically sound PBRER preparation, and ensure the signal management and risk management functions of the contract service organizations meet corporate goals and key performance indicators and maintain the audit trail of activities ready for inspection at all times
• Ensure compliance of the medical review of adverse event reports, manage preparation and submission of drug safety expedited and periodic reporting in compliance with multiple country regulations
• Develop and present assessments of safety data, safety signals, benefit and risk for internal senior management as well as external partner or regulatory authorities
• Assist in authoring of aggregate reports
• Accountable for partner liaison aspects of signal management and risk management (GVP Modules)
• Co-manage the implement of pharmacovigilance SOPs and ensure the uniform and timely processing of adverse event data in all assigned development and post-marketing programs
• Supports ad hoc safety review meetings, including all internal and external stakeholders, with compliance with signal evaluation timelines, and maintain audit trail as inspection ready at all times
• When requested, work with other BridgeBio Affiliates to provide strategic input and work on assigned non-product/compound-related projects

Preferred Qualifications

Experience in Canada, Brazil and Australia

Benefits

• Robust and market-competitive compensation & benefits package (Base, Performance Bonus, Equity)
• Patient Days, where we are fortunate to hear directly from individuals living with the conditions we are seeking to impact throughout the year and learn how we can improve our efforts
• A culture inspired by our values: put patients first, think independently, be radically transparent, every minute counts, and let the science speak
• A collaborative, fast-paced, data-driven environment where we inspire ourselves and each other to always perform at the top of our game
• Access to learning and development resources to help you get in the best professional shape of your life
• Commitment to Diversity, Equity & Inclusion