Advancing treatments to improve outcomes and quality of life for patients with hypertrophic cardiomyopathy and related heart conditions. Backed by a16z.
About the role
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.
What they're looking for
- Degree in Health Care is required (e.g., MD, DO, PhD, NP, Pharm D)
- 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 (e.g., Clinical Safety Summaries [Module 2.7.4], ISS, ISE, narratives) 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
More about this role
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.
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...
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