Stiny Suresh Email and Phone Number

● Oversee the receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial for assigned projects.● Ensure compliant safety reporting in accordance with international reporting regulations, SOPs, and safety processing guidelines, for assigned projects.● Supports preparation of pharmacovigilance reports for products and safety issues, including Individual Case Summary Reports (ICSRs) of Serious Adverse Events (SAEs).● Management of Individual Case Safety Reports (ICSRs) in various safety databases (like Arisg/LSM), case processing, writing case summaries, and assessing expectedness and causality of adverse events against drug labels.● Perform medical coding of data using CDD, WHO-DD and MedDRA. Define SOP's and writing practices of data entry conventions.● Managed the Workflow efficiently, therefore achieving high compliance rates.● Contributed to continuous process improvements by taking up training sessions and recommending ideas.● Ensure the team meet quality, productivity, and delivery standards as per project requirements.● Trained and mentored new drug safety associates and supervising and providing feedback required for Drug Safety. Also, peer review of the entered cases to verify accuracy, consistency, and compliance with process requirements.