Associate Director, Pharmacovigilance/Product Safety (Biopharmaceuticals)

Location: Fully remote; can be performed from anywhere. Occasional travel for team meetings or events is expected, with up to 10% travel annually.

Salary: $179,000–$232,500 annually.

Company

hirify.global is a global biopharmaceutical company focused on transforming the lives of patients with serious and rare diseases.

What you will do

• Provide medical expertise for product safety and risk assessment across clinical development and post-marketing stages.
• Assess the medical significance and expectedness of adverse event and serious adverse event reports and approve case narratives.
• Compile analyses of similar events, individual case comments, risk management plan analyses, and ad hoc safety assessments.
• Investigate emerging safety data from clinical trials, spontaneous reports, literature, aggregate reports, toxicology, and non-clinical studies.
• Author, review, and approve drug-safety regulatory reports and clinical study documents, including protocols, investigator brochures, integrated summaries, labeling, and MedDRA coding.
• Collaborate with safety vendors and participate in internal safety review committee meetings.

Requirements

• Master’s degree in life sciences, RN, PharmD, or MD.
• At least 3–5 years of experience as a safety officer or in a similar pharmacovigilance leadership role in the pharmaceutical industry.
• Strong experience managing safety information from clinical development and post-marketing sources.
• Expert knowledge of pharmacovigilance regulations and working knowledge of industry-standard pharmacovigilance databases and MedDRA.
• Strong leadership, communication, organizational, analytical, and attention-to-detail skills.

Nice to have

• Medical device experience.

Culture & Benefits

• Fully remote work with connection to the hirify.global team and community.
• Medical, dental, and vision coverage, mental health support, wellbeing reimbursement, and an employee assistance program.
• Paid time off, fertility and family-forming benefits, caregiver support, and flexible work schedules.
• 401(k) plan with company match, annual equity awards, employee stock purchase plan, and company-paid life and disability insurance.
• Learning programs, mentorship, employee resource groups, recognition programs, and volunteering opportunities.