Vice President, Drug Safety & Pharmacovigilance

External

Braveheartbio · San Francisco, CA

Full-timeRemote1w ago

Clinical TrialsDocumentationLeadershipRisk Management

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About the role

Braveheart Bio is a Bay Area-based biopharmaceutical company pioneering best-in-class therapies for cardiovascular disease. Our lead program is a next-generation myosin inhibitor, licensed from Hengrui Pharma, being developed to transform the treatment of hypertrophic cardiomyopathy (HCM)-the most common inherited cardiac disease. Currently in Phase 3 clinical development in China for the more common obstructive form of HCM, our candidate has demonstrated a compelling clinical profile that may position it as a best-in-class therapy with meaningful differentiation. With a proven leadership team, a strong financial foundation, and a high-value late-stage asset, Braveheart Bio represents an outstanding opportunity for ambitious, mission-driven professionals to make a tangible impact in a high-profile and rapidly evolving therapeutic area. The Vice President, Drug Safety and Pharmacovigilance will lead and scale the global drug safety and pharmacovigilance function at Braveheart Bio. Reporting into the Chief Medical Officer, the VP is accountable for the safety strategy and integrated benefit-risk profile across the portfolio, with immediate focus on supporting Phase 3 programs and preparing the organization for NDA submission and post-marketing readiness. The VP will partner with an established Senior Director of PV (a direct report) to design the PV operating model, select CRO/PV vendor partners, establish the safety governance framework, and represent Safety in cross-functional and regulatory interactions. This individual will be hands-on while setting strategic direction and has a track record of leveraging external partners to deliver inspection-ready DSPV at biotech scale.

Responsibilities

Safety Governance

Establish safety governance for the company, and chair the Safety Management/Safety Governance Committee, leading strategic oversight of safety issues, benefit-risk assessment, and decision-making across the portfolio

Establish and maintain the company's safety governance framework, including escalation pathways, decision rights, and documentation standards

Provide medical and scientific leadership in signal detection, evaluation, and risk management; develop and maintain risk management plans (RMPs) and prepare for post-marketing risk minimization where applicable

Serve as the company's safety representative in interactions with DSMBs/IDMCs

Represent the company's safety function on joint safety committees with alliance partners; drive alignment on benefit-risk assessment, signal management, and safety reporting obligations under collaboration agreements

Strategic Leadership

Oversee the definition and execution of PV strategy aligned with the company's clinical development and regulatory plans

Oversee the design of the PV operating model (insource/outsource decisions, vendor selection, governance, technology) to support multiple concurrent Phase 3 programs

Scale the function in step with pipeline progression toward commercialization

Serve as the Qualified Person responsible for PV in applicable jurisdictions (or oversee the EU-QPPV and equivalents); own the Pharmacovigilance System Master File (PSMF)

Clinical Trial Safety

Oversee medical safety review and generation of individual case safety reports (ICSRs) across clinical trials

Lead aggregate safety reporting (DSURs, IND annual reports, periodic line listings) and IB updates,

Lead safety strategy and benefit-risk assessment across protocols, IBs, CSRs, and integrated summaries (ISS), ensuring consistency with the overall clinical development and regulatory strategy.

Partner with Clinical Development on signal detection and protocol-level safety design (stopping rules, AESIs, safety monitoring plans)

Regulatory & Cross-Functional Activities

Author and/or review safety sections of regulatory submissions (IND, NDA, MAA), briefing documents, and responses to health authority queries

Represent Safety in interactions with FDA, EMA, and other regulators

Partner closely with Clinical Development, Regulatory Affairs, Medical Affairs, Biostatistics, Clinical Operations, and Quality

Lead or oversee PV audits and inspection readiness; serve as the company representative for Safety during health authority inspections

Required experience & skills:

MD strongly preferred; PharmD or RN/BSN with deep drug safety experience also strongly considered

At least 12 years of progressively senior pharmacovigilance/drug safety experience in the biopharmaceutical industry, including significant experience in late-stage development

Demonstrated experience leading safety across multiple concurrent Phase 3 programs

Prior experience chairing a Safety Management Committee, Safety Governance Committee, or equivalent cross-functional safety body

Track record of building and leading Safety/PV functions in small/emerging biotechnology/pharmaceutical company, including the build-and-leverage-CRO model

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Vice President, Drug Safety & Pharmacovigilance

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