Roles & Responsibilities
• Support project monitoring and coordination using project management tools
• Prepare study safety documents including SAE reporting forms and guidelines
• Develop training materials for investigator meetings and safety trainings
• Generate progress reports, listings, and study-related outputs for PVSM and clients
• Assist in SAE and ICSR processing as per protocols, SOPs, and regulatory guidelines
• Maintain and update internal safety databases
• Follow up with investigator sites for query resolution
• Prepare high-quality case narratives for safety reporting
• Distribute ICSRs to Ethics Committees, Investigators, and MAHs
• Prepare and circulate 6-monthly SUSAR line listings
• Support preparation and submission of DSURs to Competent Authorities and Ethics Committees
• Assist with MedDRA coding in coordination with Data Management and Statistics teams
• Support additional pharmacovigilance activities as per departmental requirements
Qualification
• Degree in Pharmacy, Life Sciences, or related discipline
Experience
• Relevant experience in Pharmacovigilance, Clinical Research, or Safety Operations
Skills
• Pharmacovigilance processes and SAE / ICSR reporting
• Safety database handling and case processing
• MedDRA coding knowledge
• ICH, EMA, and FDA regulatory guidelines
• Microsoft Office and database management tools
• Strong documentation, coordination, and communication skills
About the Organisation
Veeda Clinical Research is a leading global CRO providing comprehensive clinical research, bioanalytical, and pharmacovigilance services. The organization is known for its regulatory expertise, quality-driven processes, and strong presence in domestic and international clinical research.
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