Manager, Pharmacovigilance Operations (Biotechnology)

Location: Remote in South San Francisco, California, with frequent travel to headquarters, or hybrid onsite in South San Francisco three days per week. Candidates must be authorized to work in the United States.

Salary: $140,000–$150,000 per year, plus annual performance bonus and equity.

Company

hirify.global is a clinical-stage biotechnology company developing allogeneic CAR T-cell products for cancer and autoimmune disease.

What you will do

• Support safety vendor oversight, KPI and compliance tracking, query management, and external vendor collaboration.
• Coordinate serious adverse event reconciliation, SUSAR tracking, safety mailbox operations, access requests, and safety database activities.
• Prepare and submit periodic safety reports and regulatory filing documents, including DSURs and six-month line listings.
• Maintain safety content for Investigator Brochures, RSI, DSURs, protocols, and informed consent forms.
• Support pharmacovigilance SOPs, work instructions, SMP reviews, CAPA activities, audits, and regulatory inspections.
• Collaborate with clinical, quality assurance, study management, and other cross-functional teams.

Requirements

• Bachelor’s degree in life sciences, healthcare, or a related field; an advanced degree such as RN, BSN, or PharmD is preferred.
• At least five years of pharmacovigilance experience in a pharmaceutical or biotechnology company.
• Working knowledge of US and ex-US pharmacovigilance requirements, including US regulations, European Union GVP legislation, and ICH Guidelines.
• Proficiency with safety databases and systems such as Oracle Argus, ARISg, MedDRA, WHODrug, and SPEED.
• Strong organizational, prioritization, communication, problem-solving, and collaboration skills.
• Authorization to work in the United States is required.

Nice to have

• Experience with device safety reporting, eTMF filing, and regulatory inspections.

Culture & Benefits

• Collaborative environment with cross-functional interaction and opportunities to work independently.
• Health insurance, generous time off, and two company-wide holiday shutdowns each year.
• Annual performance bonus and equity participation.