Senior Director, Pharmacovigilance Operations & Compliance

Remote. Posted a month ago

The role

This person will manage the company's pharmacovigilance operations and compliance infrastructure. They will oversee safety operations strategy, staff, vendors, and regulatory compliance across the portfolio.

What you will do

Own and drive global PV Operations strategy
Serve as advisor to the Head of DSPV on operational risk and budget planning
Manage internal and external staff allocated to operational PV activities
Own talent strategy including hiring, development, and succession planning
Build and implement compliant pharmacovigilance systems
Provide oversight of systems and MedDRA updates
Select and manage PV vendors
Develop and implement an inspection readiness program
Serve as PV Operations lead during Health Authority inspections and audits
Oversee timely submissions of expedited reports to health authorities

Required qualifications

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
Demonstrated experience managing PV Operations through multiple Health Authority inspections
Experience spanning both clinical-stage and commercial/post-marketing environments
Skilled in process gap assessments and process enhancements
Strategic thinker
Strong execution and drive for results skills
Comfortable working independently
Deep knowledge of pharmacovigilance regulations and guidelines

Nice to have

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

Benefits

Medical insurance
Dental insurance
Vision insurance
401k match
Flexible time off
Paid holidays

About the company

Vera Therapeutics is a commercial-stage biotechnology company focused on the pursuit of truth in science to transform medicine in autoimmune disease, starting with the kidney. The company was founded in 2016 and is based in Brisbane, California.