Cencora, a global leader in pharmaceutical services, is hiring a Specialist in Pharmacovigilance Epidemiology & Risk Management for its Noida location. This is an excellent opportunity for PV professionals skilled in ICSR processing, safety data review, and regulatory reporting.
If you are looking for a Pharmacovigilance Specialist job in Noida, this role offers the perfect blend of career growth, industry exposure, and learning opportunities within a globally recognized organization.
Key Responsibilities
As a Specialist, you will handle end-to-end Pharmacovigilance activities, including:
ICSR Processing & Safety Review
Perform triage and validity assessment of spontaneous, health authority, clinical trial, and literature cases
Enter case details into the PV safety database
Conduct Initial Case Safety Report (ICSR) assessment
Regulatory Reporting & Documentation
Evaluate expedited reporting requirements to global Health Authorities
Prepare CIOMS I, MedWatch forms, and XML reports
Generate and send follow-up requests
Submit ICSRs to partners and regulators
Quality Assurance
Ensure complete documentation and case closure
Conduct quality checks to maintain compliance with industry standards
Retrieve ICSRs from the EVWEB database and perform company/non-company case assessment
Team Support
Mentor and guide new joiners
Support supervisors in executing process-specific tasks
Qualifications & Skills Required
Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Biotechnology, or related fields
Experience in ICSR processing, PV operations, safety reporting
Strong understanding of global pharmacovigilance guidelines
Proficiency in safety databases and regulatory reporting tools
