Trainee- Specialist, Pharmacovigilance, Epidemiology & Risk Management(cencora)

Roles and Responsibilities

Responsibilities:

• Conduct triage and initial validity assessments of adverse event cases from multiple sources, including spontaneous reports, health authority notifications, clinical trials, and published literature

• Perform accurate and timely data entry into pharmacovigilance databases

• Complete initial Individual Case Safety Report (ICSR) assessments in accordance with regulatory requirements

• Evaluate case criteria to determine expedited reporting obligations to Health Authorities and client partners, ensuring compliance with applicable reporting timelines

• Prepare standardized regulatory reporting forms, including CIOMS I form, MedWatch forms, and XML file formats

• Develop and transmit follow-up requests to obtain additional case information as needed

• Ensure thorough case documentation and completion in compliance with quality standards

• Conduct ICSR searches and retrieval from the EVWEB database, performing company/non-company assessments for case processing

• Undertake additional responsibilities as assigned by the supervisor based on operational and process requirements.

Educational Qualification:

• B. Pharma, M. Pharma, BDS, Life Science Graduate

Skills:

• Excellent communication skill

• Attention to detail and ability to work under regulatory timelines

• Familiarity with pharmacovigilance processes and reporting standards (preferred)