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.
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.
Key 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.
Required experience & skills:- 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, including 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
Base Salary Range: $230,000 - $325,000
This role is also eligible for a competitive total rewards package, which may include an annual bonus, equity, and a comprehensive benefits offering.
