Specialist, Pharmacovigilance Epidemiology & Risk Management

Role & Responsibilities:
• Perform triage and initial validity assessment of cases including spontaneous, health authority, clinical trial, and literature cases
• Enter and process safety data in pharmacovigilance databases
• Conduct initial ICSR assessment, where applicable
• Evaluate the need for expedited reporting to health authorities and client partners, ensuring adherence to reporting timelines
• Prepare standard safety reporting forms such as CIOMS I, MedWatch forms, and XML files
• Prepare and send follow-up requests to obtain missing or additional case information
• Submit ICSRs to health authorities and client partners
• Complete case documentation in line with project and regulatory requirements
• Conduct quality checks on ICSRs to ensure accuracy, completeness, and compliance with industry standards
• Perform ICSR search and retrieval from EVWEB database and conduct company vs non-company case assessment
• Manage case allocation and workload to meet productivity and quality targets
• Provide system and process training to team members
• Mentor and support new joiners by guiding them on company processes and fostering a collaborative learning environment
• Perform additional responsibilities as assigned by the supervisor in line with process requirements

Qualification:
• Degree in Pharmacy, Life Sciences, Medicine, or related field

Experience:
• Relevant experience in Pharmacovigilance / Drug Safety preferred

Skills:
• ICSR Processing & Case Management
• Pharmacovigilance Databases (e.g., EVWEB or similar)
• Regulatory Reporting & Compliance
• Quality Review & Documentation
• Attention to Detail & Analytical Skills
• Communication & Team Collaboration

About the Company:
• Cencora is a global healthcare solutions organization committed to creating healthier futures by improving access to medicines, enhancing patient safety, and supporting pharmaceutical innovation worldwide.