Drug Safety Associate III (Pharmacovigilance)

Location: Alameda, California, United States; office-based role

Salary: $130,500–$185,000 annually, depending on geographic market, qualifications, experience, and internal equity.

Company

hirify.global is a biotechnology and pharmaceutical company developing medicines and conducting clinical research supported by global patient safety and pharmacovigilance operations.

What you will do

• Process and assess serious adverse events from receipt through case closure in the Argus Safety Database, including queries, narratives, and ASE writing.
• Code adverse events and serious adverse events using MedDRA and maintain consistent coding conventions.
• Perform case quality reviews and schedule expedited safety report submissions.
• Oversee outsourced vendors and collaborate with Clinical Development, Clinical Operations, Data Management, Regulatory Affairs, and Project Management.
• Lead safety study activities from start-up through close-out, including safety management plans, safety forms, templates, and SAE reconciliation.
• Train new safety staff on Argus and case-processing procedures.

Requirements

• BS/BA degree in Nursing, Pharmacy, another clinical discipline, or a related field with at least 7 years of related experience; or MS/MA with at least 5 years; or PhD with 0 or more years of related experience.
• Experience in clinical trial and spontaneous adverse event processing.
• Knowledge of biotechnology or pharmaceutical operations and the regulatory framework governing patient safety.
• Analytical, organizational, planning, communication, collaboration, and issue-escalation skills.
• Ability to support study protocols, Investigator Brochures, IND Annual Reports, safety management plans, and SAE reconciliation.

Nice to have

• Biotechnology or pharmaceutical industry experience, preferably in oncology.
• Experience using the Argus Safety Database.
• Certification in the assigned area.

Culture & Benefits

• Collaborative office environment designed to support close teamwork, idea sharing, and problem solving.
• Equipment provided, including dual monitors and ergonomic chairs.
• Employee benefits include medical, dental, vision, life, disability, and flexible spending account coverage.
• 401(k) plan with company contributions, discretionary annual bonus eligibility, stock purchase opportunities, and long-term incentives.
• Fifteen accrued vacation days in the first year, 17 paid holidays including a company-wide winter shutdown, and up to 10 sick days annually.