Pharmacovigilance Manager – Front End Operations

About the role

The Manager, Pharmacovigilance – Front End Operations leads frontline support for drug safety activities, working closely with Quality Assurance, Patient Solutions, and Compliance to ensure alignment with global regulatory requirements.

Key responsibilities

• Drive execution of PV compliance activities to meet DEA, State Board of Pharmacy, URAC, ACHC, OIG and other regulatory standards.
• Partner with QA and Operations to develop, implement, and manage PV compliance frameworks, SOPs, processes, and reporting systems.
• Collaborate with cross‑functional teams (Patient Solutions, Pharmacy, Regulatory Affairs, Clinical) to integrate a patient‑centered approach.
• Maintain audit‑ready PV systems, prepare for regulatory inspections, and support internal and external audits.
• Conduct risk‑management assessments, identify compliance gaps, and recommend improvements.
• Monitor regulatory changes, communicate impacts, and update stakeholders.
• Oversee quality performance of internal and external resources and report to senior management.
• Develop and deliver PV compliance training for frontline teams.
• Facilitate preparation and submission of safety reports and risk‑management plans.
• Investigate compliance breaches and implement corrective and preventive actions (CAPAs).
• Supervise hiring, training, performance management, and professional development of staff.

Required profile

• Bachelor’s degree in Pharmacy, Life Sciences or a related scientific discipline, or equivalent experience.
• Minimum 7 years of experience in pharmacovigilance or drug safety.
• Strong knowledge of US drug‑safety regulations and audit processes.

Required skills

What we offer

• Opportunity to lead a critical safety function within a dynamic organization.
• Collaborative environment with cross‑functional teams.
• Professional growth and development in regulatory compliance.