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    Senior Manager, Drug Safety And Pharmacovigilance

    Bridgebio
    3+ years
    $150,000-$200,000 USD
    United States
    10 Feb. 14, 2025
    Job Description
    Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Senior Manager, Drug Safety and Pharmacovigilance

    Company: BridgeBio Pharma
    Location: USA (Remote)
    Benefits Offered: Medical, Paid Time Off, Retirement

    About BridgeBio

    BridgeBio is a biopharmaceutical company focused on discovering, creating, testing, and delivering transformative medicines for patients with genetic diseases and genetically-driven cancers. Founded in 2015, the company has developed a diverse portfolio of 20+ drug development programs spanning various therapeutic areas, including genetic dermatology, precision oncology, cardiology, endocrinology, neurology, pulmonology, and renal disease, with two approved drugs.

    BridgeBio operates U.S. offices in San Francisco, Palo Alto, and Raleigh, with international offices in Montreal, Canada, and Zurich, Switzerland. The company is actively expanding across Europe. To learn more, visit BridgeBio.

    Who You Are

    The Senior Manager, Drug Safety & Pharmacovigilance will oversee all drug safety functions of CROs and play a key role in the Safety Management Team. This role requires close collaboration with Clinical Operations, QA, Clinical Research, Regulatory Affairs, and Medical Writing to support drug safety operations.

    Responsibilities:

    • Manage drug safety contract service organizations (CSOs) to ensure compliance with expedited reporting (>=95%) and timely, scientifically sound DSUR preparation.
    • Maintain safety document management in Trial Master File and Veeva.
    • Act as the primary contact for CSOs to oversee daily safety-related activities.
    • Collaborate with CSOs and external partners to ensure regulatory reporting compliance.
    • Develop and maintain the safety management plan for clinical trials and post-marketing safety activities.
    • Design and oversee end-to-end processes for CSO handling of individual case safety reports (ICSRs).
    • Ensure compliance with global drug safety regulations, including FDA, EMA, and MHRA.
    • Monitor the safety mailbox for assigned affiliates.
    • Oversee and review the safety section of the electronic trial master file (eTMF) for compliance.
    • Draft and maintain safety data exchange agreements (SDEAs) and pharmacovigilance agreements (PVAs).
    • Manage internal safety and pharmacovigilance files to ensure an audit-ready state.
    • Work with internal and external data management teams on electronic data capture (EDC) reporting of serious adverse events (SAEs) and adverse events of special interest (AESIs).
    • Collaborate with data management for ongoing reconciliation of clinical and safety databases.
    • Provide safety-related updates in study management team (SMT) meetings.
    • Assist with data collection and review of safety data to support signal detection.
    • Contribute to safety SOPs and department initiatives.
    • Provide strategic input and work on assigned non-product/compound-related projects across BridgeBio affiliates.

    Required Qualifications:

    • Bachelor’s degree in a healthcare-related field; advanced degree preferred.
    • Minimum of three (3) years of drug safety and pharmacovigilance experience, with at least one (1) year of oversight management experience.
    • Experience in both clinical development and post-marketing safety activities.
    • Knowledge of regulatory submissions for NDAs, EU MAAs, and other regulatory reviews.
    • FDA and EMA inspection experience for new drug approvals.
    • Experience in growing a clinical trial drug safety system into a global post-marketing PV system.
    • Proven ability to manage drug safety teams or CSOs for clinical programs.
    • Expertise in safety signal evaluation, management, and tracking.
    • Familiarity with GCP, FDA, ICH regulations, and global drug safety compliance.
    • Experience in working with cross-functional clinical trial teams.
    • Strong knowledge of clinical trial safety databases and safety reporting (Argus, ArisG, or VeevaSafety).
    • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Project, Outlook).
    • Willingness to travel periodically.

    What We Offer:

    • Patient Days – Direct interactions with individuals affected by conditions BridgeBio aims to treat.
    • A collaborative, fast-paced, and data-driven environment.
    • Competitive compensation, performance bonus, and equity options.
    • Health, welfare, and retirement programs.
    • Flexible PTO and opportunities for rapid career advancement.
    • Potential to work on multiple programs across different therapeutic areas.
    • A commitment to diversity, equity, and inclusion.

    Salary Range:

    $150,000 - $200,000 USD (California-based candidates). Final salary may vary based on experience, education, location, and interview performance. BridgeBio is a multi-state employer, and this salary range may not apply to other locations.

     

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