Director, Drug Safety and Pharmacovigilance, International

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BridgeBio

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2015

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Description

• BridgeBio is a biopharmaceutical company focused on discovering and delivering transformative medicines for genetic diseases and cancers. • Responsible for managing all aspects of drug safety functions related to international markets. • Collaborate with Clinical Operations, QA, Clinical Research, Regulatory Affairs, and Medical Writing to establish safety strategy for international expansion markets. • Lead pharmacovigilance safety management across all partner markets and ensure compliance with regulatory requirements. • Manage international product labelling, RMPs, new drug applications, safety label updates, and other reports as necessary. • Ensure uniform and timely processing of adverse event data in development and post-marketing programs.

Requirements

• Bachelor’s degree in a health care discipline or equivalent is required, and an advanced degree is preferred • Requires at least ten years of drug safety and pharmacovigilance experience (post-market safety experience in 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; experience in Canada, Brazil and Australia preferred • 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%

Benefits

• Patient Days, where we hear directly from individuals living with conditions we seek 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