Job Details

Director/Senior Director, Pharmacovigilance Operations

*Hybrid Opportunity (2-3x per week onsite in Redwood City, CA)*

Meet has partnered with an exciting biotech in the rare disease space that is looking for a Director of Pharmacovigilance/Drug Safety Operations to join their team.

Key Responsibilities

• Review individual and aggregate adverse event reports for potential PV/Drug Safety issues.
• Ensure that AEs from spontaneous reports, solicited reports, and literature cases involving company products are collected, analyzed, and handled in accordance with all global/local regulatory requirements and company policies.
• Manage PV vendors to ensure compliance and effectiveness.
• Serve as an SME for processing ICSR's for clinical-stage programs and commercial products.
• Collaborate with, and provide PV guidance and support for interdepartmental or corporate initiatives.

Key Qualifications

• BS required, advanced degree preferred (PharmD, PhD)
• 10+ years of direct experience in PV/Drug Safety
• Strong understanding of US and EU PV guidelines

Please reach out if you're interested in learning more:

✉: ...@meetlifesciences.com