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Senior Director, Pharmacovigilance
2 days ago
About us:
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 role:
The Senior Director, Pharmacovigilance (PV) will lead Braveheart's global PV strategy and partner closely with Clinical, Regulatory, and other development functions to drive operational excellence and full compliance with regulatory safety obligations. Reporting to the Vice President of Regulatory Affairs, Pharmacovigilance and Safety, this individual will play a pivotal role in preparing the organization for global Phase 3 execution. This includes leading all PV contributions to Investigational New Drug (IND) and Clinical Trial Application (CTA) submissions worldwide, with responsibility for developing high-quality safety sections, maintaining compliance, and supporting readiness for major regulatory milestones. The role requires ongoing, proactive collaboration with our external development partner— harmonizing safety data exchange, aligning on safety surveillance strategies, and co-developing a unified safety profile for the shared asset. In addition, this leader will be instrumental in shaping the future PV function— its people, structure, and operating model— as Braveheart transitions from clinical development to post-market commercialization.
Key responsibilities:
- Lead strategic and operational activities for the PV department.
- Responsible for all PV operations and compliance aspects of all Braveheart's products throughout the product lifecycle
- Build and oversee PV infrastructure, PV systems and PV processes to support the growing volume and complexity of safety data generated by our global Phase 3 program and partnered studies
- Oversee the process for ICSR collection, processing, reconciliation, and reporting, including associated quality activities to ensure regulatory timelines and global standards are met
- Serve as the drug safety expert for regulatory submissions, leading PV contributions to relevant sections and responses to queries from regulatory authorities
- Develop and oversee the process for signal detection, evaluation, and management
- Provide PV operational expertise in the development of RMPs, aggregate safety reports, REMS, and other safety deliverables
- Provide review, analysis and medical guidance during the case handling and reporting process for serious AEs (SAEs) received for the Braveheart investigational products
- Contribute to safety sections of clinical study documents including Study Protocols, Informed Consent Forms (ICF), Clinical Study Reports (CSR), IB Reference Safety Information (RSI), and other relevant documents
- Lead vendor selection and provide vendor oversight for all outsourced PV activities, including establishing and monitoring key quality and compliance metrics
- Responsible for the development and maintenance of Safety Management Plans and PV Agreement/Safety Data Exchange Agreement with license partners and distributors
Required experience & skills:
- Degree in Health Care is required (e.g., MD, DO, PhD, NP, Pharm D)
- At least 12 years of experience in drug development at global pharmaceutical or biotechnology companies, including at least 8 years of experience in PV operations in the clinical trial and post-marketing environments
- Strong knowledge of global regulations governing pharmacovigilance in the pharmaceutical industry and Research & Development processes
- Experience in writing safety sections (2.7.4, ISS, narratives) of marketing applications, and successfully defending contents to Health Authorities
- Strong interpersonal and communication skills for bridging between scientific and business participants, for negotiating timelines and for effective international collaboration
- 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
Expected Base Salary Range: $325K - $376K
We are an equal opportunity employer.
We are committed to inclusion and diversity, and we do not discriminate on the basis of race, gender, religion, gender, sexual orientation, age, color, marital status, veteran status, disability status, national origin, or any characteristic protected under applicable law.
