Director, Pharmacovigilance & Global Safety Operations

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

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.