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Senior Director, Pharmacovigilance

10+ years
$230K/yr - $280K/yr
10 March 21, 2025
Job Description
Job Type: Full Time Education: BS/PharmD/PhD Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Senior Director, Pharmacovigilance
Location: San Francisco Bay Area (Hybrid, 2-3x per week onsite in Redwood City, CA)
Salary: $230K - $280K per year
Type: Full-time

About the Role:
Our client, an innovative biotech company in the rare disease space, is seeking a Director/Senior Director of Pharmacovigilance (PV)/Drug Safety Operations to join their team.

Key Responsibilities:

  • Review individual and aggregate adverse event reports for potential PV/Drug Safety issues.

  • Ensure that adverse events (AEs) from spontaneous reports, solicited reports, and literature cases involving company products are collected, analyzed, and handled according to global/local regulatory requirements and company policies.

  • Manage PV vendors to ensure compliance and operational effectiveness.

  • Serve as a subject matter expert (SME) for processing Individual Case Safety Reports (ICSRs) for clinical-stage programs and commercial products.

  • Collaborate with interdepartmental teams and provide PV guidance and support for corporate initiatives.

Key Qualifications:

  • Education: BS required; advanced degree preferred (PharmD, PhD).

  • Experience: 10+ years of direct experience in PV/Drug Safety.

  • Strong understanding of US and EU PV guidelines.

Contact Information:
For more information, please contact:
Email:
ryan.moran@meetlifesciences.com