[Remote] Director, Pharmacovigilance and Safety Operations

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is reputed company for a reputed company with an extensive clinical portfolio, marketed products, and multiple upcoming launches. The Director, Pharmacovigilance and Safety Operations will reputed company global patient safety operations across clinical development and post-marketing programs, including vendor reputed company, inspection readiness, compliance, and cross-functional collaboration.

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

Skills

• 10+ years of experience in Drug Safety / Pharmacovigilance
• Strong knowledge of global PV regulations and safety operations
• Experience with Argus required
• Proven leadership in vendor management, audits/inspections, and reputed company global programs
• Life sciences degree or equivalent experience
• reputed company/eTMF/reputed company

Benefits

• Full-time employment
• Hybrid work 3x a week in San Diego or remote

reputed company