Syed Ibrahim

Pharmacovigilance Specialist @ProPharma

Conduct daily case processing of adverse event reports. • Data entry of post-marketed serious and/or non-serious individual case safety reports ensuring compliance with client Standard Operating Procedures (SOP) and Work Instructions (WI). • Identify and select the cases from workflow, determining appropriate prioritization criteria and submission dates. • Coding of suspect, concomitant, treatment and previously prescribed drug using Company Drug Dictionary and WHO Drug Dictionary. • Verifying the data entered cases for accuracy, consistency, and compliance with process requirements. Use MedDRA Coder Browser (MCB) to code adverse events, indications of suspect and concomitant medications, medical history and laboratory investigations as per coding conventions. • Prepare medical narratives and assign MedDRA terms to adverse events while maintaining consistency with Argus database. • Generate follow up letters and do necessary phone calls as per determined follow up needs to obtain targeted missing case information and clarifications. • Perform validity, seriousness, expectedness/labeledness/listedness and determine causality using the WHO - UMC system. • Prepare and review MedWatch/CIOMS/E2B reports for various global regulatory authorities. • Perform quality review of ICSR which includes review of source documents and ensuring that the case is accurate and that corrections to the case, if applicable, are incorporated. • Assist with ensuring that periodic and expedited safety reports comply to both internal and regulatory timelines with strong knowledge of periodic reporting including PADER/DSUR/PSUR/PBRER. • Perform literature search as per search strategy using global literature databases. • Complete client notifications as required for case management. • Develop training materials, conduct training presentations, and on-the-job training for call center, medical information and pharmacovigilance staff.