Chetan Khedkar

To perform review of the safety case files and safety database. To ensure all data elements, as provided by the reporter, are entered accurately and appropriately in safety database including other reference numbers. To ensure dechallenge & rechallenge data has been entered accurately and appropriately. To ensure Seriousness & Expectedness assessment are performed accurately & appropriately. To verify the source and assessment documents are present and complete. Provide feedback to the Data Entry associate.

To provide triage of incoming cases to determine seriousness for prioritization of daily workflow. To document and process Serious Adverse Event reports, spontaneously reported adverse events, and other medically related information per study specific procedures. Case data entry including narrative writing and MedDRA coding in ARGUS database. To draft documentation suitable for submission to regulatory agencies and the preparation of aggregate safety reports . To assist Medical Monitor with documentation.

To provide triage of incoming cases to determine seriousness for prioritization of daily workflow. To document and process Serious Adverse Event Reports, spontaneously reported adverse events, and other medically related information per study specific procedures. To draft documentation suitable for submission to regulatory agencies and the preparation of aggregate safety reports. To train and mentor medical and administrative staff; train extra-departmental staff as requested.

Capturing the ADE (adverse drug events) experienced by the consumers while using the products manufactured by the company and sending them to the DSP (Drug Safety and Pharmacovigilance) for further processing. Provide medical information to consumer regarding the dosage and the ingredients and about the usage of the products.

Quality checking of the raw material as well as finished products. Reporting problems relating to the quality of the products and forwarding the same to the QA department.

Quality checking of the raw material as well as finished products. Reporting problems relating to the quality of the products and forwarding the same to the QA department.

International Business

Pharmacy