Senior Director, Pharmacovigilance

Braveheart Bio•San Francisco, CA

About The Position

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.

Requirements

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

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