Director, Pharmacovigilance Operations

Responsibilities

• Develop strategy for PV operations and support PV Head in implementing the PV vision
• Provide strategic leadership for global pharmacovigilance operations, including case management, vendor oversight and aggregate reporting
• Manage implementation of the safety system for regulatory-compliant ICSR case processing
• Oversee PV vendor and contract management, including CROs and partners
• Oversee safety-related alliance management (SDEAs)
• Manage information flow between clinical and PV vendors
• Oversee quality and compliance for ICSR case processing and reporting (KPIs)
• Maintain ICSR case processing SOPs, forms and SMPs
• Support timely dissemination of safety deliverables and lead PV audit and inspection contributions
• Manage PV project deliverables, TMF contributions, budget and resources
• Coach and mentor PV operations associates

Requirements

• Health care professional degree or advanced degree in life sciences
• Minimum 8 years of pharmacovigilance experience in biopharma, at least 3 in leading PV operations
• Experience with safety data review, vendor management, aggregate reports, signal detection and risk management plans
• Experience with MedDRA and drug coding reviews
• Expertise in global PV regulations, GVP and ICH guidelines
• Strong communication and cross-functional collaboration skills

Preferred Qualifications

• MBA or PMP
• Experience in neuroscience, psychiatry or neurodegenerative disease

Benefits

• Annual bonus opportunity, medical, dental, vision, life and disability insurance
• 401(k) with match, stock options, flexible paid time off, parental leave

About the Company

• Clinical-stage biotech focused on drug discovery for central nervous system disorders.