Senior Director, Pharmacovigilance Job at Meet Life Sciences, Sonoma, CA

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  • Meet Life Sciences
  • Sonoma, CA

Job Description

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:

✉: ryan.moran@meetlifesciences.com

Job Tags

Local area,

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