Senior Specialist Case Processing

Roles & Responsibilities
• Perform triage and initial validity assessment of ICSRs including spontaneous, clinical trial, health authority, and literature cases
• Carry out data entry and end-to-end case processing in pharmacovigilance safety databases
• Conduct initial case assessments and determine expedited reporting requirements
• Prepare and submit CIOMS I forms, MedWatch forms, and XML files
• Manage follow-up requests and ensure timely case closure
• Submit ICSRs to global health authorities and business partners as per timelines
• Perform quality checks (QC) to ensure compliance with regulatory and project standards
• Conduct EVWEB case searches and company versus non-company case assessments
• Support case allocation and workload distribution within the team
• Provide system training, guidance, and mentoring to new team members
• Contribute to continuous process improvement and adherence to global PV regulations

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

Experience
• Minimum 1.5 years of hands-on experience in ICSR case processing
• Experience working with pharmacovigilance databases and global safety reporting

Skills
• Strong understanding of ICSR workflows and regulatory reporting timelines
• High attention to detail with a strong quality and compliance mindset
• Excellent written and verbal communication skills in English
• Ability to prioritize tasks and manage workload independently
• Good mentoring skills and ability to work collaboratively within teams

About the company
Cencora is a global leader in healthcare solutions, supporting pharmaceutical, biotech, and healthcare partners across the product lifecycle, and through its affiliate PharmaLex India Private Limited, the company delivers high-quality regulatory affairs, pharmacovigilance, and compliance services worldwide, with a strong focus on patient safety, scientific excellence, and regulatory integrity.