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About the Role
The Senior Director, Pharmacovigilance (PV) will lead the company's global drug safety and pharmacovigilance strategy, ensuring operational excellence, regulatory compliance, and effective surveillance and reporting. This role is critical for preparing the organization for Phase 3 execution, regulatory submissions, and commercialization, including managing global co-development partnerships and scaling the PV infrastructure.
Responsibilities
- 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, ensuring adherence to global regulatory requirements and reporting timelines.
- Build, scale, and continuously improve PV infrastructure, systems, processes, and oversight frameworks to support global Phase 3 programs and future commercialization.
- 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, including DSURs, PBRERs/PSURs, IND Annual Reports, Investigator Brochures, and other safety deliverables.
- 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, including preparation of safety sections and responses to regulatory queries.
- Provide case review, analysis, and guidance during SAE case assessment, reporting, and safety issue escalation activities for Braveheart investigational products.
- Contribute to safety sections of clinical and regulatory documents, including protocols, informed consent forms, investigator brochures, clinical study reports, integrated safety summaries, and marketing application submissions.
- Serve as the operational pharmacovigilance lead for global co-development and licensing partnerships, including oversight of Safety Data Exchange Agreements (SDEAs), Pharmacovigilance Agreements (PVAs), safety governance activities, and partner safety data reconciliation.
- Lead selection, management, and oversight of PV vendors, CROs, and external service providers, including development and monitoring of quality, compliance, and performance metrics.
- Support pharmacovigilance inspection readiness activities, audits, CAPA management, and continuous process improvement initiatives.
Requirements
- 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 (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.
- 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, 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.
Skills
- Pharmacovigilance
- Drug Safety
- Global Regulations
- Aggregate Safety Reports (DSURs, PBRERs/PSURs, IND Annual Reports, Investigator Brochures, RSI)
- Safety Surveillance
- Signal Detection
- Signal Evaluation
- Benefit-Risk Assessment
- Risk Management
- Marketing Application Safety Sections
- Regulatory Submissions (INDs, CTAs, NDA/BLA/MAA)
- Health Authority Queries
- Safety Data Exchange Agreements (SDEAs)
- Pharmacovigilance Agreements (PVAs)
- Safety Management Plans
- Co-development Partnerships
- Vendor Management (CROs, PV vendors)
- Inspection Readiness
- Audits
- CAPA Management
- Interpersonal Skills
- Communication Skills (Written and Verbal)
- Teamwork
- Adaptability
- Proactiveness
Experience Level
- Senior Director
- 10+ years in drug development
- 7+ years in pharmacovigilance and drug safety
Education Level
- Degree in Health Care (e.g., MD, DO, PhD, NP, Pharm D)
Salary/Compensations
- $230,000 - $325,000
Benefits
- Competitive total rewards package
- Annual bonus
- Equity
- Comprehensive benefits offering
About the Company
- 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.
Equal Opportunity
- 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.
- Braveheart participates in the federal E‑Verify program to confirm employment authorization for all new hires.