Manager, Pharmacovigilance
AssistRx - Orlando, FL
Hiring: Manager, Pharmacovigilance Company: AssistRx Location: Orlando, FL Job Posted Time: 2026-09-02 22:39:31 Target Skills & Keywords : Compliance About the job Experience: •7+ years of experience in pharmacovigilance/drug safety, with 3+ years in a compliance, oversight, or quality-driven role. Required Skills: •Strategically drive execution of PV compliance activities to meet global regulatory requirements (DEA, State Board of Pharmacy, URAC and ACHC, OIG, etc.) and industry standards, with a focus on operational integration with Quality Assurance and Patient Solutions. •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. Qualifications: •Education: Bachelor’s degree in a scientific discipline (Pharmacy, Life Sciences, etc.) or equivalent experience required. •Experience: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. •Practical experience utilizing health authority inspections (e.g., DEA, State Board of Pharmacy, URAC and ACHC, OIG, etc.) and audit readiness. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!