Senior Director, Pharmacovigilance

<div class="content-intro"><p><strong>About us:</strong></p> <div> <p class="x_MsoNormal"><span data-olk-copy-source="MessageBody">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.</span></p> </div> <div> <p class="x_MsoNormal">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.</p> </div> <p> </p></div><p><strong>The role:</strong></p> <p>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, and regulatory compliance.</p> <p>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, and 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) and Pharmacovigilance Agreements (PVAs), management of safety data exchange and reconciliation activities, and 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.</p> <p><strong>Key responsibilities:</strong></p> <ul> <li>Lead strategic and operational pharmacovigilance activities supporting Braveheart's development and future commercial portfolio.</li> <li>Oversee all PV operations and compliance activities throughout the product lifecycle, ensuring adherence to global regulatory requirements and reporting timelines.</li> <li>Build, scale, and continuously improve PV infrastructure, systems, processes, and oversight frameworks to support global Phase 3 programs and future commercialization.</li> <li>Oversee ICSR collection, case review, processing, reconciliation, reporting, and associated quality activities.</li> <li>Lead safety surveillance activities, including signal detection, evaluation, management, and communication of emerging safety risks.</li> <li>Provide scientific and operational leadership for aggregate safety reporting activities, including DSURs, PBRERs/PSURs, IND Annual Reports, Investigator Brochures, and other safety deliverables.</li> <li>Support development and implementation of Risk