Case processing, literature review, ICSR downloads, Reconciliation

•Case processing and Quality control of ICSR in ISS (International Safety Suite) in accordance with the updated guidelines.• Medical data study and medical terminology coding using MedDRA, WHO-DD.• Understanding of ICH guidelines.• Understanding of safety studies related to newly approved COVID-19 VACCINE.• Assessment of relatedness of events associates with COVID-19 vaccination and drugs according to company specifications.• Handling of spontaneous reports from European Medicines Agency (EMA) and Medicines and Healthcare products Regulatory Agency (MHRA).• Knowledge of case triage, descriptive narrative writing, generating queries pertinent to the cases.

• Doping Analysis: Horse urine: As per Association of OfficersRacing Chemist (AORC) and International Federation of HorseRacing Authorities (IFHA) in all categories of drug.Human urine: As per World Anti-Doping Association (WADA)in selected categories of drugs.• Wet chemistry- Biological sample preparation for dopinganalysis.• Analytical chemistry- Sample analysis on LC-MS/MS andGC-MS/MS and GC-MSD.

• As peer reviewer: Book-in and migrate case in ARGUS inaccordance with the mapping updates.Data entry.• As Quality analyst: To perform quality check of the migratedcases.Escalating the findings to concerned person.• As PV Officer: Performing data entry in lifecycle Safetydatabase for the data provided in patients profile from varioussources as per the standard operating procedure.Updating case information by coding relevant medicalterminologies such as drug, event, and disease.Assessing causality relationship.Writing descriptive narratives. Generating queries pertinent to thecases.Performing Quality control. All as per the standard operatingprocedures.