Vinay Jadhav

I am a highly skilled and experienced Drug Safety Associate with a total of 3 years and 2 months of experience in handling and processing ICSR cases of all types including literature, direct/partner spontaneous, and E2B importing. Currently, Skilled in EMA (EudraVigilance) activity and partner E2B importing, with experience in processing documents according to company standards and regulatory timelines.

• Triage and Data entry the case based on regulatory timeline and seriousness.
• Review the ICSR (Individual case safety report) for its validity, seriousness and possible adverse event.
• Currently worked in EMA (EudraVigilance) activity and partner E2B importing
• Process the documents as per company standard and Regulatory timelines.
• Collection and data entry of relevant information regarding patient, drug, adverse event(s) in safety gathering system software i.e. ARGUS (Analytical reports gathering and updating system).
• Coding of Drug with Company drug dictionary as well as WHO drug dictionary.
• Coding of Adverse event to most its specific term available in MedDra and code the seriousness of that adverse event as per the source document.
• Coding of possible diagnosis and symptoms that occurred because of the drug.
• Write narrative according to regulatory and company standard.

• Commitment to quality and results.
• Confident and focused.
• Having Good Leadership Quality.
• Quick grasping power and hard working.

• Date of Birth: 08/13/97
• Nationality: Indian
• Marital Status: Single