Director, Pharmacovigilance and Safety Operations

FlexBoard; India; On-site; INR 15,282,000 - 22,923,000; Full time

Job summary

FlexBoard seeks an Associate Director/Director, Pharmacovigilance Operations to lead global PV activities across clinical development and post-marketing programs. The role governs safety operations, vendor management, inspection readiness, and cross-functional collaboration to ensure regulatory compliance and robust patient safety practices.

The ideal candidate will bring 10+ years in Drug Safety, strong PV regulation knowledge, and leadership in vendor management.

Qualifications

• Minimum 10+ years in Drug Safety / Pharmacovigilance.
• Strong knowledge of global PV regulations and safety operations.
• Experience with Argus required; eTMF/Global PV programs experience preferred.

Responsibilities

• Day-to-day drug safety and PV operations across clinical and post-marketing programs.
• Coordinate with licensed partners and cross-functional teams for safety activities.
• Oversee case processing workflows, vendor performance, KPIs, and CAPAs.
• Support PV agreements, safety data exchange, and partner collaborations.
• Ensure inspection/audit readiness with proper documentation and regulatory support.
• Maintain and improve SOPs and operational processes.

Skills

Drug Safety

Pharmacovigilance

PV Regulations

Vendor Management

Leadership

Education

Life Sciences Degree

Tools

Argus PV

eTMF

Job description

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

• day-to-day drug safety and PV operations across clinical and reputed company programs
• communication and operational interfaces with licensed partners across clinical development and reputed company programs
• 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.