Director, Pharmacovigilance

Jobtailor; Seattle (WA); On-site; USD 110,000 - 180,000; Full time

Job summary

Jobtailor in Seattle seeks an experienced pharmacovigilance professional to oversee case processing, safety reporting, and data integrity across global programs. The role requires an in-depth PV background and collaboration with cross‑functional teams.

With 10+ years in biotech/pharma PV, you will lead regulatory submissions and safety reporting, ensuring compliance with FDA/EMA/ICH guidelines, and manage PV vendors and data systems. Oncology/cell/gene therapy experience is a plus.

Qualifications

• Pharmacovigilance experience: at least 10 years in biotech/pharma.
• Experience supporting clinical-stage programs.
• Working knowledge of global PV regulations (FDA, EMA, ICH).
• Familiarity with aggregate reporting and signal detection processes.
• Experience in oncology, cell therapy, or gene therapy preferred.

Responsibilities

• Oversee case processing activities, including intake, triage, medical review support, and expedited reporting.
• Ensure compliance with global safety reporting requirements (FDA, EMA, ICH guidelines).
• Manage relationships with PV vendors/CROs, ensuring service quality, timeliness, and data integrity.
• Support maintenance of safety databases and related systems.
• Lead preparation of DSURs, PSURs/PBRERs, and IND safety reports.
• Support safety sections of regulatory submissions and responses to health authority queries.
• Contribute to development and maintenance of SOPs and Pharmacovigilance System Master File (PSMF).

Education

Advanced degree (PharmD, PhD, MD, or MS) or health‑related degree/certification (PA, RN, NP)

Job description

Responsibilities

• Oversee case processing activities, including intake, triage, medical review support, and expedited reporting
• Ensure compliance with global safety reporting requirements (FDA, EMA, ICH guidelines)
• Manage relationships with PV vendors/CROs, ensuring service quality, timeliness, and data integrity
• Support maintenance of safety databases and related systems
• Lead preparation of DSURs, PSURs/PBRERs, and IND safety reports
• Support safety sections of regulatory submissions and responses to health authority queries
• Contribute to development and maintenance of SOPs and Pharmacovigilance System Master File (PSMF)

Requirements

• Advanced degree (PharmD, PhD, MD, or MS) or health‑related degree/certification (PA, RN, NP)
• At least 10 years of pharmacovigilance experience in biotech or pharmaceutical industry
• Experience supporting clinical‑stage programs
• Working knowledge of global pharmacovigilance regulations (FDA, EMA, ICH)
• Familiarity with aggregate reporting and signal detection processes
• Experience in oncology, cell therapy, or gene therapy preferred