A fast-growing pharmaceutical organization in Raleigh, NC that’s reshaping the generics industry with a global, patient-first mindset is seeking a Senior Pharmacovigilance Associate to lead drug safety and risk management activities. This hybrid position plays a pivotal role in drug safety oversight and regulatory compliance, including signal detection, adverse event reporting, REMS program participation, and cross-functional collaboration. The role supports both routine safety operations and strategic growth initiatives. The ideal candidate is analytical, detail-obsessed, and thrives in a collaborative, high-standards environment. Manager-level applicants are also welcome and encouraged to apply.

Senior Pharmacovigilance Associate Responsibilities: 

• Monitor and evaluate adverse event reports to ensure regulatory compliance with global authorities including FDA, EMA, and ICH
•  Conduct signal detection and risk assessments to identify emerging safety concerns
• Prepare and review aggregate safety reports, including PSURs and Risk Management Plans
• Serve as the point of contact for REMS programs and oversee Safety Data Exchange Agreements
• Develop and maintain SOPs, policies, and workflows for pharmacovigilance operations
• Provide training and guidance on global PV regulations and best practices across internal teams
• Collaborate cross-functionally with clinical, regulatory, and medical affairs groups to align on safety initiatives
• Support audits and inspections and ensure readiness for internal and external pharmacovigilance reviews
• Oversee end-to-end PV operations and supervise core functions and/or junior staff

Senior Pharmacovigilance Associate Requirements: 

• Bachelor’s degree in Pharmacy, Life Sciences, or related field (Master’s or PharmD preferred)
• 2–5+ years of pharmacovigilance or drug safety experience in a regulated environment
• Deep understanding of global PV regulations and case processing requirements
• Prior experience using pharmacovigilance databases and tools
• Strong analytical and risk assessment skills with a high attention to detail
• Proven background in regulatory affairs, clinical safety, or drug development
• High level of professionalism, work ethic, and a growth-oriented mindset

Benefits:

• Comprehensive medical, dental, and vision coverage
• Generous PTO
• 401(k) plan with 5% employer match
• Life and disability insurance (STD/LTD), FSA, and floating holidays
• Transparent merit-based promotions and annual reviews
• Culture of respect, flexibility, and shared purpose in a fast-paced, mission-driven team

Apply Now!

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