[Hiring] Senior Director, Pharmacovigilance @Braveheart Bio

Role Description

The Senior Director, Pharmacovigilance (PV) will serve as a key leader within Braveheart Bio's Drug Safety and Pharmacovigilance organization, partnering closely with the Vice President, Drug Safety and Pharmacovigilance to execute the company's global drug safety and pharmacovigilance strategy and ensure excellence in:

• Pharmacovigilance operations
• Safety surveillance
• Signal management
• Aggregate reporting
• Vendor oversight
• Regulatory compliance

This role will play a critical part in preparing the organization for global Phase 3 execution, regulatory submissions, and eventual commercialization. The Senior Director will provide strategic and operational leadership for:

• Safety surveillance
• Signal detection and management
• Aggregate safety reporting
• Risk management
• Pharmacovigilance compliance
• Outsourced PV operations

The role will also serve as the operational pharmacovigilance lead for Braveheart's global co-development partnership, ensuring effective safety governance, implementation and oversight of:

• Safety Data Exchange Agreements (SDEAs)
• Pharmacovigilance Agreements (PVAs)
• Management of safety data exchange and reconciliation activities
• Alignment of safety surveillance, aggregate reporting, and benefit-risk assessments across global development programs

In addition, this leader will help scale Braveheart's pharmacovigilance infrastructure, systems, processes, and operating model to support the organization's evolution from late-stage clinical development through regulatory approval and commercialization.

Qualifications

• Degree in Health Care is required (e.g., MD, DO, PhD, NP, Pharm D)
• At least 10 years of experience in drug development at global pharmaceutical or biotechnology companies
• At least 7 years of experience in pharmacovigilance and drug safety across clinical development and post-marketing environments
• Strong knowledge of global regulations governing pharmacovigilance in the pharmaceutical industry and Research & Development processes
• Experience authoring and/or overseeing aggregate safety reports, including DSURs, PBRERs/PSURs, IND Annual Reports, Investigator Brochures, and Reference Safety Information (RSI)
• Experience with safety surveillance, signal detection, signal evaluation, benefit-risk assessment, and risk management activities
• Experience in writing safety sections of marketing applications and successfully defending contents to Health Authorities
• Experience supporting global regulatory submissions, including INDs, CTAs, NDA/BLA/MAA submissions, and responses to Health Authority safety queries
• Experience developing and maintaining Safety Data Exchange Agreements (SDEAs), Pharmacovigilance Agreements (PVAs), and Safety Management Plans
• Experience working with co-development, licensing, or alliance partners, including safety data reconciliation and partner oversight
• Experience selecting, managing, and overseeing CROs, pharmacovigilance vendors, and outsourced service providers
• Experience supporting pharmacovigilance inspections, audits, CAPA management, and inspection readiness activities
• Strong interpersonal and communication skills for bridging between scientific and business participants
• Strong written and 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

Requirements

• Lead strategic and operational pharmacovigilance activities supporting Braveheart's development and future commercial portfolio
• Oversee all PV operations and compliance activities throughout the product lifecycle
• Build, scale, and continuously improve PV infrastructure, systems, processes, and oversight frameworks
• Oversee ICSR collection, case review, processing, reconciliation, reporting, and associated quality activities
• Lead safety surveillance activities, including signal detection, evaluation, management, and communication of emerging safety risks
• Provide scientific and operational leadership for aggregate safety reporting activities
• Support development and implementation of Risk Management Plans (RMPs), REMS, Safety Management Plans, and other risk management activities
• Serve as the pharmacovigilance subject matter expert for regulatory submissions and health authority interactions
• Provide case review, analysis, and guidance during SAE case assessment, reporting, and safety issue escalation activities
• Contribute to safety sections of clinical and regulatory documents
• Serve as the operational pharmacovigilance lead for global co-development and licensing partnerships
• Lead selection, management, and oversight of PV vendors, CROs, and external service providers
• Support pharmacovigilance inspection readiness activities, audits, CAPA management, and continuous process improvement initiatives

Benefits

• Base Salary Range: $230,000 - $325,000
• Eligible for a competitive total rewards package, which may include an annual bonus, equity, and a comprehensive benefits offering

Company Description

Braveheart Bio is a clinical-stage biopharmaceutical company focused on developing therapies for patients with hypertrophic cardiomyopathy (HCM) and other serious cardiovascular diseases. Our lead product candidate, BHB-1893, is a next-generation oral small-molecule cardiac myosin inhibitor (CMI) being developed for the treatment of obstructive HCM (oHCM) and non-obstructive HCM (nHCM).

Braveheart’s goal is to improve the treatment options for these patients by enhancing speed of onset, depth of gradient response, systolic safety, reversibility and reducing prescribing complexity.

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.