Webinar - The new QMS Normal Post COVID19 for the Pharma, Life Sciences & Medical Device Companies

Personnel Involved

Senior Pharmacovigilance Consultant & Auditor

  • Physician by training with 2.5 years of clinical experience.

  • Seasoned drug safety professional with over 7 years of experience in pharmacovigilance, working in oncology therapeutic area and supporting global product safety teams.

  • Accountable for safety related aspects of products including providing medical input to scheduled and non-scheduled regulatory reports.

  • Experienced in working in the following therapeutic areas: Oncology, Established products, Cardiovascular and Metabolics, Immunology/ Autoimmune Diseases.

  • Experienced in authoring/reviewing and providing medical inputs into key regulatory documents including, but not limited to, periodic benefit risk evaluation reports (PBRERs)/periodic safety update reports (PSURs), drug safety/ad-hoc reports, health hazard evaluation (HHE) reports, development safety update reports (DSUR), and clinical overview

  • Trained in MedDRA coding in accordance with "MedDRA Term Selection: Points to Consider"

  • Trained in handling the Enterprise Resource and Planning (ERP) tool.

  • For System Demo and further information, please call +91 98100 68241 or mail us at bd@crqa.in