Director, Drug Safety & Pharmacovigilance

Summary

Join BridgeBio as Director of Drug Safety and lead the pharmacovigilance efforts across international markets. You will manage all aspects of drug safety functions for partner organizations, ensuring compliance with global regulations. Collaborate with various teams to develop safety strategies and manage safety data. This role requires extensive experience in drug safety and pharmacovigilance, including regulatory submissions and agency inspections. The position is based in Zug, Switzerland, with remote work options in Switzerland and the Netherlands. BridgeBio offers a competitive compensation and benefits package, a collaborative environment, and opportunities for professional development.

Requirements

• Bachelor’s degree in a health care discipline or equivalent is required
• Requires at least ten years of drug safety and pharmacovigilance experience (post-market safety experience in the biotechnology, pharmaceutical, drug safety contract service organization (CSO)) with at least three years of oversight management experience (line management or CSO management)
• Experience in both clinical development and post-marketing safety
• Experience with Regulatory submissions for NDAs, EU MAAs, and other countries’ Regulatory reviews
• QPPV service management and oversight, PSMF authoring experience
• 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
• Demonstrated ability to successfully manage drug safety team or drug safety CRO for clinical and post-marketing programs with responsibilities for ICSR collection, expedited reporting, on-time PSUR preparation, and meeting corporate goals and key performance indicators
• Safety signal management, and tracking, including supporting regulatory documentation
• Experience in drug safety audits and agency inspections as case processing, PSUR, and CSO management subject matter expert
• Intimate knowledge of GCP and strong working knowledge of FDA or other agencies, Good Clinical Practices, and ICH regulations and guidelines
• Experience in working with clinical trial and post-marketing teams, including data management, clinical sciences, medical monitors, clinical operations, biostats, regulatory, medical writing, medical liaisons, call center, and QA
• Experience in investigating and managing potential product quality defects
• Management of compliance deviations and formulations of CAPAs
• Post-marketing labelling experience as it pertains to safety
• Familiar with clinical trial safety database use and CIOMS II and PSUR reporting generation (Argus, ArisG, or VeevaSafety) and Microsoft Office Suite required (Word, Excel, PowerPoint, Project, Outlook)
• Must be able and willing to travel up to 30%

Responsibilities

• Lead the pharmacovigilance agreement negotiation between BridgeBio and the local distribution organisations
• Lead the BridgeBio international pharmacovigilance safety management across all partner markets and in collaboration with the local distribution organisation
• Host and perform pharmacovigilance safety audits across all partner organisations and markets
• Ensure compliance with pharmacovigilance regulatory requirements across all partner organisations and markets
• Manage all aspects of safety and pharmacovigilance for assigned products to ensure compliant and sound safety strategy in both clinical trials and the post-marketing setting for the geography in scope
• Manage international product labelling, RMPs, new drug applications, safety label updates, and other reports as necessary
• Manage international critical documents, including protocol and ICFs
• Manage the drug safety contract service organizations (CSOs) for clinical programs with >=95% compliance with expedited reporting, manage on-time and scientifically sound local safety report preparation, and ensure the drug safety functions of the CSOs meet corporate goals and key performance indicators
• Develop and prepare assessments of safety data, safety signals, and benefits/risks for internal senior management as well as external partner or regulatory authorities
• Manage the authoring of aggregate reports and other local safety reports as required
• Manage 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
• Manage ongoing reconciliation of incoming safety information and the safety databases
• Act as a liaison with external collaborators to develop processes to meet regulatory reporting requirements
• Develop and prepare reports for company management as well as external regulatory agencies
• Ensure compliance with standard operating procedures and clinical trial and post-market global drug safety regulations, including to the FDA, EMA, MHRA, and all assigned international RAs
• Implement pharmacovigilance SOPs and ensure the uniform and timely processing of adverse event data in all assigned development and post-marketing programs
• When requested, work with other BridgeBio Affiliates to provide strategic input and work on assigned non-product/compound-related projects

Preferred Qualifications

• An advanced degree is preferred
• Experience in Canada, Brazil and Australia preferred

Benefits

• 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
• Robust and market-competitive compensation & benefits package (Base, Performance Bonus, Equity)
• Commitment to Diversity, Equity & Inclusion