Pharmacovigilance Manager
Core
Overseeing pharmacovigilance activities to ensure the safety and efficacy of clinical trial products throughout their lifecycle.
Role type
Manager, Pharmacovigilance
Builds
Drug safety monitoring activities and regulatory compliance for clinical trial products
Domain
Healthcare / Clinical Research / Pharmacovigilance
Deliverable
client delivery
Required skills
Pharmacovigilance operations, case processing, safety reporting, aggregate reporting, line management, team coaching, performance management, project management, global PV regulations (GVP/GCP), SOPs, quality systems, resource management, capacity planning, data analysis, trend identification, process improvement, Microsoft Office proficiency, stakeholder communication
Preferred skills
Project management with resource planning and risk management
Technologies
Microsoft Excel, PowerPoint, Word, reporting/analytics tools
Responsibilities
Leading the PV team in collecting, evaluating, and reporting adverse events; developing and implementing PV processes and policies; collaborating with clinical, regulatory, and QA teams; providing training and guidance on PV regulations; monitoring and analyzing safety data trends and preparing risk assessments; ensuring compliance with global regulatory requirements and internal quality standards.
Seniority
Manager, hands-on leadership
