Location: San Diego, CA; Brisbane, CA; OR Princeton NJ
Job Summary
The Vice President, Head of Pharmacovigilance – Safety Science, is responsible for overseeing all aspects of product safety across clinical development and post-marketing surveillance. This key leadership role ensures that pharmacovigilance (PV) activities align with regulatory requirements and company standards, and drives the strategy and execution of safety science to protect patient health and optimize product benefit-risk profiles. The VP works cross-functionally with clinical, regulatory, medical affairs, quality, and commercial teams to support the safe use of products globally.
Responsibilities
- Pharmacovigilance Strategy and Oversight
- Develop and lead the global pharmacovigilance strategy to ensure proactive risk management and compliance with local and international PV regulations (e.g., FDA, EMA, ICH).
- Oversee end-to-end PV activities, including case processing, safety surveillance, risk management, and signal detection and assessment.
- Establish and maintain robust safety governance structures, ensuring alignment with company objectives and industry best practices.
- Safety Science and Risk Management
- Direct safety evaluation and risk management for clinical and post-marketing products, including benefit-risk assessments, aggregate reporting, and product safety strategy.
- Lead the detection, evaluation, and management of safety signals, collaborating with cross-functional teams to implement risk minimization strategies and communicate potential safety concerns.
- Oversee safety aspects of regulatory submissions, periodic safety reports (e.g., DSURs, PSURs, RMPs), and responses to regulatory inquiries.
- Cross-Functional Leadership and Stakeholder Engagement
- Partner with clinical, regulatory, and medical affairs teams to integrate safety insights into product development, clinical trial design, and labeling strategies.
- Act as the key PV representative for interactions with global regulatory authorities and stakeholders, advocating for patient safety.
- Engage with external experts, scientific bodies, and industry groups to stay updated on evolving PV practices and enhance the organization’s safety profile.
- Team Leadership and Development
- Lead and mentor a high-performing pharmacovigilance and safety science team, fostering a culture of collaboration, accountability, and scientific excellence.
- Define and implement processes for continuous improvement within PV operations, safety science, and risk management.
- Manage the PV budget, ensuring alignment with organizational priorities and effective use of resources.
- Up to 25% travel if not located in San Diego.
Education and Experience
- MD, PharmD, PhD, or other advanced degree in a relevant field.
- 15+ years of experience in pharmacovigilance, safety science, or related area within the pharmaceutical/biotechnology industry, with a proven track record of leadership. Experience in Solid Tumors Oncology is required.
- In-depth knowledge of global pharmacovigilance regulations and guidelines, including FDA, EMA, and ICH.
- Strong understanding of clinical development, post-marketing safety, and regulatory submissions.
- Demonstrated expertise in signal detection, risk management, benefit-risk assessment, and aggregate safety reporting.
- Experience interacting with global regulatory authorities and scientific advisory bodies.
- Exceptional leadership, strategic thinking, and communication skills.
Skills and Qualifications
- Experience leading a large team within a global organization.
- Proven ability to work effectively in a matrixed, cross-functional environment.
- Demonstrated commitment to patient safety and ethics in medical practice.
The starting compensation for this job is a range from $312,000 – $390,000 plus incentive cash and stock opportunities (based on eligibility). The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation will be decided based on demonstrated experience.
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