Profile: Experienced Drug Safety/Pharmacovigilance professional with a demonstrated history of working in the pharmaceuticals industry since 10 years. Regulatory lead for safety reporting group. Trained on CER writing. Experienced in team handling. Experienced in handling of both external and internal Audit. Participated in Vendor qualification audit - Skilled in ARGUS safety database and Medidata RAVE. Experience in handling medical devices reports and study. ICSR complete case processing. Safety Reporting for RA and sites as per regulatory requirements . Experienced in processing Periodic reports - Preparation of Safety Management plan. Authoring of DSUR SOP. Budget and forecasting of various projects. People management & Team training. Workflow Management. Project Management activities. Developed audit finding response documents based on investigation meetings with stakeholders. Experienced in performing through investigation, comply with high quality Root cause analysis (RCA), develop Corrective action and Preventive action (CAPA) with effectiveness check. Performed Vendor audits. Investigational site audit for clinical trial projects. Ok in Auditing for any English-speaking country, preferably. However, have handled audit in Japan with the help of Senior Auditor and translator. Languages known: In India ,very fluent with Hindi, English and at beginner level for Tamil and Bengali. Based in Bengaluru.
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