Associate Director, Global Medical Review

Location: Princeton, New Jersey, United States; on-site availability is required when needed for critical business activities, audits, inspections, and regulatory interactions. International travel of up to 15% may be required, with after-hours meetings with Japan.

Salary: $186,489–$278,875 annually, plus incentive opportunity.

Company

hirify.global Pharmaceutical Companies develops and commercializes pharmaceutical products and provides comprehensive employee benefits.

What you will do

• Lead and oversee medical review activities for Individual Case Safety Reports, ensuring quality, consistency, compliance, and performance against established metrics.
• Assess safety data, adverse event trends, emerging risks, and benefit-risk considerations for assigned products.
• Support audits, health authority inspections, inspection readiness, observation responses, CAPAs, and corrective actions related to Medical Review.
• Develop, revise, implement, and maintain Medical Review SOPs, work practices, job aids, and guidance documents.
• Provide guidance, training, feedback, and oversight to vendor medical reviewers and facilitate global reviewer alignment meetings.
• Partner with Medical Safety Product Leaders, PV Operations, Regulatory Affairs, Clinical Development, Quality, affiliates, and vendors on safety governance, labeling, and emerging safety information.

Requirements

• M.D. from an accredited medical school and at least 5 years of pharmaceutical-industry safety surveillance experience.
• Experience with development products and launched or post-marketed products.
• Experience interacting with global regulatory authorities, including EMA, MHRA, PMDA, and Health Canada.
• Strong knowledge of global pharmacovigilance regulations, MedDRA, safety databases, clinical trials, Good Clinical Practice, and ICH guidelines.
• Prior supervisory and vendor oversight experience, including inspection representation and regulatory interaction support.
• Strong scientific data analysis, communication, strategic thinking, leadership, and Microsoft application skills.

Nice to have

• Experience in immunology, neurology, or rare diseases.
• Experience working in a global, cross-functional pharmaceutical environment.

Culture & Benefits

• Comprehensive medical, dental, vision, and prescription drug coverage.
• Company-provided life, accidental death and dismemberment, and short- and long-term disability insurance.
• Tuition reimbursement and student loan assistance.
• Generous 401(k) match, flexible time off, paid holidays, and paid leave programs.
• Work includes collaboration across global pharmaceutical and pharmacovigilance functions.