Vera Therapeutics is a biotechnology company dedicated to advancing treatments for serious immunological diseases. We are seeking a Vice President of Pharmacovigilance to lead our global drug safety strategy and ensure proactive benefit-risk assessments across our innovative portfolio of therapies.
Key responsibilities
- Lead global clinical safety, pharmacovigilance, and risk management activities throughout the product lifecycle.
- Build and manage a high-performing, inspection-ready pharmacovigilance team while promoting operational excellence.
- Provide strategic oversight for safety sections of regulatory documents, including BLA, MAA, and NDA filings.
- Ensure robust processes for case processing, aggregate reporting, signal detection, and risk management.
- Advise leadership on safety matters and collaborate cross-functionally with Clinical Development, Regulatory Affairs, and Quality Assurance.
Requirements
- MD degree with Board Certification in a relevant therapeutic area.
- Over 10 years of experience in pharmacovigilance leadership, including at least 3 years in an executive capacity.
- In-depth knowledge of global pharmacovigilance regulations, including ICH, FDA, and EMA guidelines.
- Proven success in establishing or scaling post-marketing pharmacovigilance systems in a biotech environment.
- Strong communication skills and a commitment to ethical standards and continuous improvement.
What we offer
- Opportunity to shape the safety strategy for a growing clinical-stage biotechnology company.
- Comprehensive benefits package including medical, dental, and vision insurance.
- Participation in annual performance incentive bonuses and equity programs.
- A collaborative environment focused on improving patient outcomes.