Vice President, Drug Safety & Pharmacovigilance

The role:

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.

Key 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
• Deep working knowledge of global PV regulations and guidance: FDA 21 CFR, ICH E2A–E2F, EU GVP modules, and emerging FDA safety guidance
• Experience with health authority inspections and audit readiness
• Strong writing and presentation skills, with demonstrated ability to communicate complex safety data clearly to internal stakeholders, boards, regulators, and external partners
• Strategic thinker who is also willing to roll up sleeves at biotech scale
• Excellent judgment under uncertainty; high integrity and discretion
• Demonstrated ability to influence without authority across a matrixed, fast-moving environment
• Strong verbal communication skills with a collaborative, team-oriented approach
• Ability to thrive in a fast-paced, dynamic environment and remain comfortable with change and ambiguity
• Flexible, proactive, and hands-on mindset with a roll-up-your-sleeves, can-do attitude

Preferred experience & skills:

• Prior experience supporting a successful BLA/NDA filing and approval
• Therapeutic area experience in cardiovascular medicine

Base Salary Range: $330K – $400K