Director, Pharmacovigilance / Product Safety

Location: Fully remote; can be performed from anywhere. Occasional U.S. and domestic travel of up to 20% is expected for team meetings, events, and other activities.

Company

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

What you will do

• Review safety data from preclinical research, clinical trials, post-marketing sources, and scientific literature.
• Lead safety signal detection, monitoring, evaluation, interpretation, management, and communication.
• Lead Safety Review Teams and manage ongoing cross-functional benefit-risk assessments.
• Develop and manage risk management systems, Risk Management Plans, Risk Minimization Measures, and REMS when required.
• Provide medical safety input on clinical and regulatory documents, including protocols, informed consent forms, investigator brochures, INDs, CTAs, and clinical study reports.
• Collaborate with Clinical Development, Regulatory Affairs, Quality Assurance, Medical Affairs, Manufacturing, Legal, and other global functions.

Requirements

• MD or DO degree with at least 2 years of clinical patient care experience.
• At least 5 years of pharmaceutical industry experience in drug safety or pharmacovigilance covering investigational and marketed products.
• At least 3 years of experience with medical case reviews, aggregate reporting, safety surveillance, signal management, and/or risk management.
• Knowledge of national and international pharmacovigilance and regulatory guidelines, including ICH and EU GVP.
• Ability to review or prepare scientific and regulatory documents from large volumes of scientific information.
• Proficiency with Microsoft Word, Excel, PowerPoint, Outlook, and Adobe Acrobat.

Nice to have

• Experience presenting drug safety topics to regulatory authorities at conventions or meetings.
• Experience defending products before national or international regulatory authorities.
• Knowledge of drug safety databases.

Culture & Benefits

• Fully remote work with purposeful in-person collaboration and occasional travel.
• Medical, dental, vision, and mental health coverage, plus annual wellbeing reimbursement and an Employee Assistance Program.
• Paid time off, fertility and family-forming benefits, caregiver support, and flexible work schedules.
• 401(k) with company match, annual equity awards, Employee Stock Purchase Plan, and company-paid life and disability insurance.
• Learning programs, LinkedIn Learning access, workshops, mentorship, networking, employee resource groups, and service programs.