Manager, Pharmacovigilance

Summary

Join our team as Manager, Pharmacovigilance - Front End Operations to lead frontline operational support for pharmacovigilance activities, ensuring consistent alignment with global regulatory requirements. Drive the execution of PV compliance activities, partner with cross-functional teams, and ensure PV systems are audit-ready.

Requirements

• Education: Bachelor’s degree in a scientific discipline (Pharmacy, Life Sciences, etc.) or equivalent experience required
• 7+ years of experience in pharmacovigilance/drug safety, with 3+ years in a compliance, oversight, or quality-driven role
• Strong knowledge of global PV regulations, including ICH guidelines and GVP Modules
• Experience with health authority inspections (e.g., DEA, State Board of Pharmacy, URAC and ACHC, OIG, etc.) and audit readiness

Responsibilities

• Drive the execution of PV compliance activities to meet global regulatory requirements (DEA, State Board of Pharmacy, URAC and ACHC, OIG, etc.) and industry standards
• Partner closely with Quality Assurance and Operations to develop, implement, and manage PV compliance frameworks, including SOPs, processes, and systems for program drug safety reporting
• Work directly with cross-functional teams, including Patient Solutions, Pharmacy, Regulatory Affairs, and Clinical, to facilitate an integrated and patient-centered approach to PV compliance
• Ensure PV systems are audit-ready, including preparing for and supporting regulatory authority inspections
• Conduct regular assessments of PV risk management, identify and address compliance gaps, and recommend improvements in collaboration with QA and Patient Solutions
• Monitor regulatory changes in PV and assess their impact on front-end operations, keeping stakeholders informed of updates and required actions
• Oversee and assess quality performance of internal and external resources, regularly reporting to senior management
• Support internal and external PV audits, including audits of business partners and service providers, ensuring findings are communicated and addressed
• Contribute to the development and delivery of PV compliance training tailored to frontline and patient solutions teams
• Facilitate the timely preparation and submission of regulatory filings related to PV, including safety reports and risk management plans
• Assist in investigations of compliance breaches, implementing corrective and preventive actions (CAPAs) as needed
• Actively engage in continuous improvement initiatives to enhance PV processes and ensure quality integration across all frontline operations

Preferred Qualifications

• Experience in biopharmaceutical or biotechnology industries preferred
• Certification in pharmacovigilance, compliance, or related fields preferred
• Familiarity with PV databases and safety signal detection tools preferred