Sr. Medical Director, Drug Safety & Pharmacovigilance @BridgeBio Pharma

[Hiring] Sr. Medical Director, Drug Safety & Pharmacovigilance @BridgeBio Pharma

Apr 01, 2025 - BridgeBio Pharma is hiring a remote Sr. Medical Director, Drug Safety & Pharmacovigilance. 💸 Salary: $300,000 - $340,000 usd. 📍Location: USA.

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Role Description

An experienced safety physician who will lead the postmarketing safety strategy for your assigned products, working closely with highly motivated colleagues eager to bring safe, new treatments to patients. This role requires a keen ability to work collaboratively, adapt and find solutions to complex problems, and drive results.

Responsible for comprehensive oversight and strategic oversight of core safety information and local labeling, postmarketing safety data review, benefit-risk assessment, and risk management.
Subject matter expert during agency inspections.

Responsibilities

Overall risk management and safety strategy of assigned products, including internal and external engagement with key collaborators.
Oversight and understanding of all aspects of the assigned product’s safety profile from clinical development to post-approval safety surveillance.
Chair of the Safety Management Committee for the designated product(s), responsible for identifying emerging safety trends and recommending safety actions.
Establish the safety strategy for postmarketing safety, core safety information, local labeling, safety reporting, benefit-risk evaluation, and risk management.
Participate in publication preparation and medical information material review.
Manage medical aspects of aggregate data analysis and presentation of medical analyses internally and to regulatory agencies.
Assist in the medical review of adverse event reports and manage preparation and submission of drug safety expedited reporting.
Develop and present assessments of safety data, safety signals, benefits, and risks for internal senior management and external partners or regulatory authorities.
Assist in the authoring of aggregate reports.
Accountable for partner liaison aspects of signal management and risk management.
Support ad hoc safety review meetings with compliance with signal evaluation timelines.
Work with other BridgeBio Affiliates on assigned non-product/compound-related projects when requested.

Qualifications

Medical Degree.
At least 12 years of drug safety and pharmacovigilance experience.
Extensive experience with safety signal evaluation, data review and analysis, and authoring regulatory correspondence.
Experience in both clinical development and post-marketing safety.
Experience with Regulatory submissions for NDAs, EU MAAs, and other countries’ Regulatory reviews.
Demonstrated ability to manage drug safety teams or drug safety CSOs.
Experience in drug safety audits and global agency inspections.
Intimate knowledge of GCP and strong working knowledge of FDA, Good Clinical Practices, and ICH regulations.
Proven ability to collaborate with postmarketing teams.
Experience in managing postmarketing safety aspects of product quality defect investigations.
Familiar with clinical trial safety database use and reporting generation.
Must be able and willing to travel periodically for face-to-face engagements with regulatory authorities.

Benefits

Patient Days to hear directly from individuals living with the conditions we are seeking to impact.
A culture inspired by values: put patients first, think independently, be radically transparent, every minute counts, and let the science speak.
A de-centralized model that enables program teams to focus on advancing science and helping patients.
A place where you own the vision for your program and career path.
A collaborative, fast-paced, data-driven environment.
Access to learning and development resources.
Robust and market-competitive compensation & benefits package.
Flexible PTO.
Rapid career advancement for strong performers.
Potential ability to work on multiple BridgeBio Pharma programs across multiple therapeutic areas.
Partnerships with leading institutions.
Commitment to Diversity, Equity & Inclusion.

Salary

$300,000 — $340,000 USD

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📍	Be aware of the location restriction for this remote position: USA
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Sr. Medical Director, Drug Safety & Pharmacovigilance @BridgeBio Pharma

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Salary 💸 $300,000 - $340,000 usd	Remote Location USA
Job Type unspecified	Posted Apr 01, 2025

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📍	Be aware of the location restriction for this remote position: USA
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[Hiring] Sr. Medical Director, Drug Safety & Pharmacovigilance @BridgeBio Pharma

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