Director, Pharmacovigilance - San Diego, CA

Summary

The Director, Pharmacovigilance (PV) will lead and oversee safety reporting activities across clinical programs, with a primary focus on managing and coordinating pharmacovigilance deliverables with Contract Research Organizations (CROs). This role ensures compliance with global regulatory requirements, company SOPs, and high-quality execution of safety reporting obligations. This position will act as the key liaison between internal stakeholders and CRO partners to drive operational excellence and regulatory compliance in pharmacovigilance activities.

Responsibilities

• Oversee all safety reporting activities managed by CROs, including expedited reporting (SAEs, SUSARs) and periodic aggregate safety reports (DSURs, PSURs/PBRERs).
• Serve as the primary point of contact for CRO pharmacovigilance teams, ensuring clear communication, accountability, and delivery of safety obligations.
• Develop, negotiate, and manage PV sections of contracts, safety management plans, and operational agreements with CROs.
• Monitor CRO performance through KPIs, audits, and oversight activities, ensuring timely and accurate reporting to regulatory authorities, ethics committees, and investigators.
• Lead safety reporting governance, including escalation of significant safety issues, compliance deviations, and regulatory queries.
• Collaborate with internal stakeholders (Clinical Development, Regulatory Affairs, Quality, Legal) to ensure alignment on PV strategy and compliance.
• Provide oversight for case processing, medical review, and data reconciliation activities performed by CROs.
• Ensure compliance with global regulations (FDA, EMA, MHRA, ICH, GVP, etc.) and maintain inspection readiness.
• Support development and maintenance of internal PV policies, SOPs, and training programs.
• Participate in safety signal detection activities and safety governance committees, as needed.
• Oversee maintenance and compliance of an externally hosted electronic safety database for tracking, storing, and reporting of serious adverse events.
• Participate in regulatory inspections and PV audits to ensure quality, integrity, and compliance with pharmacovigilance and safety reporting requirements per SOPs and global regulations.

Experience and Qualifications

• Bachelor's degree; advanced degree a plus.
• 10 or more years of pharmacovigilance experience, including at least 5 years in a leadership or oversight role.
• Strong experience managing CRO/vendor relationships, particularly in clinical trial safety reporting.
• Deep knowledge of global pharmacovigilance regulations, GVP, ICH guidelines, and relevant reporting requirements.
• Experience with oversight of drug safety databases (e.g., Oracle Argus).
• Proven track record of ensuring compliance in a global PV environment.

Skills and Abilities

• Strong ability to build and maintain excellent interpersonal relationships, both within and outside the company, at all levels, and work within, lead and motivate a cross-functional matrixed team.
• Self-motivated; engaged, hands-on, entrepreneurial style with a sense of urgency, a bias toward action, and flexibly contribute simultaneously in multiple facets of drug development; willingness to learn new therapeutic areas.
• Analytical and problem-solving skills; risk identification and management; creative and innovative thinking.
• The requisite scientific acumen and communication skills to influence and collaborate with key scientific, regulatory, and business leaders.
• Sound strategic, clinical, technical, operational, and ethical judgment with uncompromising integrity.
• Excellent communication, negotiation, and leadership skills.

The expected base pay range for this position is $195,000 – $220,000 plus bonus, equity, and comprehensive benefits. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training. This range may be modified in the future.

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