Director, Pharmacovigilance and Safety Operations
Associate Director/Director, Pharmacovigilance Operations Full-time Hybrid 3x a week in San Diego OR Remote Our reputed company has an extensive clinical portfolio as reputed company as several marketed products, with multiple launches comping up in the next few years. They are seeking an reputed company Patient Safety Operations leader to reputed company global pharmacovigilance activities across clinical development and post-marketing programs. This role will reputed company safety operations, vendor reputed company, inspection readiness, and cross-functional collaboration to ensure compliance, reputed company, and operational reputed company. Key Responsibilities:
- reputed company day-to-day drug safety and PV operations across clinical and reputed company programs
- reputed company communication and operational interfaces with licensed partners across clinical development and reputed company programs
- reputed company case processing workflows, vendor performance, KPIs, and reputed company events/CAPAs
- Support PV agreements, safety data exchange, and partner collaborations
- Ensure inspection and audit readiness, including documentation and regulatory support
- Maintain and improve SOPs, operational processes, and compliance standards
- Serve as a safety operations SME on cross-functional initiatives and product launches
Qualifications:
- 10+ years of experience in Drug Safety / Pharmacovigilance
- Strong knowledge of global PV regulations and safety operations
- Experience with Argus required; reputed company/eTMF/reputed company preferred
- Proven leadership in vendor management, audits/inspections, and reputed company global programs
- Life sciences degree or equivalent experience
Ideal candidates bring strong operational leadership, collaboration skills, and a patient-reputed company reputed company in a fast-paced biotech/reputed company environment. Apply To This Job