Director, Pharmacovigilance (Biotech)

Location: Seattle, Washington, United States; onsite at least 2 days per week. Remote work may be available within the United States, with travel to Seattle at least 5 days per month.

Salary: $204,000–$305,000 annually.

Company

hirify.global is a biotech company developing off-the-shelf cancer therapies through an integrated immunotherapy platform.

What you will do

• Oversee pharmacovigilance case processing, intake, triage, medical review support, expedited reporting, and safety data management.
• Ensure compliance with FDA, EMA, and ICH safety reporting requirements.
• Manage PV vendors and CROs, including service quality, timelines, and data integrity.
• Prepare or contribute to DSURs, PSURs/PBRERs, IND safety reports, regulatory submissions, and health authority responses.
• Support signal detection, trend analysis, safety review meetings, and Risk Management Plans.
• Maintain audit- and inspection-ready PV processes while driving continuous improvement.

Requirements

• Advanced degree such as PharmD, PhD, MD, or MS, or a health-related degree or certification such as PA, RN, or NP.
• At least 10 years of pharmacovigilance experience in the biotech or pharmaceutical industry.
• Experience supporting clinical-stage programs and outsourced PV models.
• Strong knowledge of global pharmacovigilance regulations, including FDA, EMA, and ICH requirements.
• Experience with safety databases, case processing workflows, aggregate reporting, and signal detection.
• Ability to manage external partners and influence cross-functional teams in a fast-paced biotech environment.

Nice to have

• Experience with regulatory submissions and inspections.
• Experience in oncology, cell therapy, or gene therapy.
• Familiarity with Argus or ArisGlobal safety databases.

Culture & Benefits

• Individual contributor role with responsibility for PV vendors and CRO relationships.
• Potential to build the future pharmacovigilance team and organization.
• Medical, dental, and vision insurance plans.
• 401(k) plan with a 100% match on the first 4% of employee deferrals.
• Paid time off, commuter benefits, and a cell phone stipend.