Senior Director, Pharmacovigilance Operations & Compliance

Responsibilities

• Own and drive global PV Operations strategy in close alignment with the Head of DSPV
• Own accountability for the DSPV Operations budget, including CRO and vendor contract spend
• Manage internal and external staff allocated to operational PV activities
• Provide vendor oversight and management for all outsourced or insourced PV activities
• Serve as PV Operations lead during Health Authority inspections and audits
• Oversee timely submissions of expedited safety reports to health authorities
• Build and implement pharmacovigilance systems compliant with worldwide regulations
• Lead training activities, including setting training requirements and compliance

Requirements

• Healthcare or life sciences degree
• 15+ years of pharmacovigilance experience
• 5+ years in a people-leadership role managing global PV teams
• Experience with clinical and commercial lifecycle phases
• Experience managing PV Operations through multiple Health Authority inspections
• Deep knowledge of pharmacovigilance regulations and guidelines

Preferred Qualifications

• Advanced degree (PharmD, RN, MPH, or scientific PhD)
• Experience across multiple therapeutic areas

Benefits

• Annual performance incentive bonus and equity
• Medical, dental, and vision insurance, 401k match, flexible time off, paid holidays

About the Company

• Vera Therapeutics is a commercial-stage biotechnology company focused on autoimmune disease, starting with the kidney. Headquartered in Brisbane, California.