Specialist Case Processing

Roles & Responsibilities
• Perform triage and initial validity assessment of safety cases including spontaneous, health authority, clinical trial, and literature cases
• Enter and process case data accurately in pharmacovigilance (PV) safety databases
• Conduct initial ICSR assessment and determine applicability for expedited reporting
• Evaluate reporting requirements and timelines for submission to health authorities and client partners
• Prepare standard regulatory reporting forms such as CIOMS I, MedWatch forms, and XML files
• Generate, send, and track follow-up requests to obtain complete safety information
• Submit Individual Case Safety Reports (ICSRs) to global health authorities and client partners
• Ensure complete case documentation and timely case closure as per SOPs
• Perform quality checks on ICSRs to ensure compliance with project requirements, regulatory standards, and best practices
• Conduct ICSR search and retrieval activities from EVWEB and perform company versus non-company case assessments
• Mentor and support new team members by guiding them on processes and fostering a collaborative learning environment
• Execute additional responsibilities as assigned by the supervisor in line with process requirements

Qualification
• University degree in Life Sciences such as Pharmacy, Biotechnology, Clinical Research, or a related discipline

Experience
• Minimum 2 years of hands-on experience in pharmacovigilance
• Strong working knowledge of ICSR processing, case triage, and safety reporting workflows

Skills
• Good written and verbal communication skills
• Ability to identify issues and suggest practical solutions within area of expertise
• Strong attention to detail and quality-focused mindset
• Good understanding of global PV regulations and reporting timelines
• Ability to work independently and collaboratively within a team

About the company
Cencora is a global healthcare solutions organization dedicated to improving patient outcomes by supporting pharmaceutical and life sciences companies across the product lifecycle, and through its affiliate PharmaLex India Private Limited, it delivers specialized services in pharmacovigilance, regulatory affairs, and compliance, with a strong commitment to quality, ethics, and patient safety worldwide.