Drug Safety Associate II (Pharmacovigilance)

Location: Alameda, California, United States; office-based working conditions

Salary: $104,500–$148,000 annually

Company

hirify.global is a biotechnology and pharmaceutical company focused on developing and commercializing medicines, including oncology therapies.

What you will do

• Process and assess serious adverse events from receipt through case closure in the Argus Safety Database.
• Generate queries and prepare case narratives and adverse event summaries.
• Perform MedDRA coding for serious and non-serious adverse events and help maintain coding conventions.
• Conduct case quality reviews with support from the Drug Safety Physician.
• Schedule expedited safety report submissions and oversee related outsourced vendor activities.
• Collaborate with Clinical Development, Clinical Operations, Data Management, Regulatory Affairs, and Project Management.

Requirements

• BS/BA in Nursing, Pharmacy, a clinical discipline, or a related field with at least 5 years of related experience; or MS/MA with at least 3 years; or a PhD with 0 or more years of related experience.
• Experience processing clinical-trial and spontaneous adverse events.
• Knowledge of biotechnology/pharmaceutical operations and the regulatory framework governing patient safety.
• Analytical, organizational, planning, communication, and collaboration skills.
• Ability to follow predefined procedures, prioritize task-related challenges, and implement solutions.

Nice to have

• Experience in the biotechnology or pharmaceutical industry.
• Oncology experience.
• Experience using the Argus Safety Database.
• Certification in the assigned area.

Culture & Benefits

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