Associate Director, Pharmacovigilance/Product Safety

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

• Assess the medical significance and expectedness of AE/SAE reports and approve case narratives prepared by vendors or internal teams.
• Compile analyses of similar events, individual case comments, risk management plans, and ad hoc safety analyses.
• Provide medical input for post-marketing safety commitments and periodic benefit-risk assessment reports.
• 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, informed consent forms, investigator brochures, integrated safety and efficacy summaries, labeling, and MedDRA coding.
• Coordinate medical review activities with drug safety vendors and participate in internal safety review committee meetings.

Requirements

• Master’s degree in life sciences, or an RN, PharmD, or MD.
• At least 3–5 years of experience as a safety officer or in a similar pharmacovigilance leadership role within 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 flexible schedules and purposeful in-person collaboration.
• Medical, dental, vision, and mental health coverage, plus annual wellbeing reimbursement and an employee assistance program.
• Paid time off, fertility and family-forming benefits, and caregiver support.
• 401(k) 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.