Associate Director, Pharmacovigilance/Product Safety (Biopharma)

Location: Fully remote and can be performed from anywhere; occasional team-meeting or event travel is expected, with travel of up to 10% annually.

Company

hirify.global is a global biopharmaceutical company developing treatments for patients with serious and rare diseases.

What you will do

• Provide medical significance and expectedness assessments for adverse event and serious adverse event reports.
• Review and approve case narratives prepared by internal teams and safety vendors.
• Compile analyses of similar events, individual case comments, risk management plans, and ad hoc safety data.
• Investigate emerging safety information 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.
• Collaborate with 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 standard pharmacovigilance databases and MedDRA.
• Strong leadership, communication, organization, attention to detail, and analytical 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, equity awards, employee stock purchase plan, and company-paid life and disability insurance.
• Learning programs, mentorship, employee resource groups, service programs, and recognition opportunities.