Meghraj Kuchekar
Drug Safety Associate @IQVIA
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WORK HISTORY
Drug Safety Associate @IQVIA
Pune, IN
Adverse Event (AE) Reporting: Collect, process, and follow up on adverse event reports from healthcare professionals, patients, and clinical trials.* Data Review & Assessment: Evaluate the safety data for accuracy, completeness, and clinical relevance.* Regulatory Compliance: Prepare and submit safety reports to regulatory authorities (e.g, FDA, EMA) in accordance with global guidelines.* Documentation: Maintain detailed records of safety data and ensure proper documentation of all pharmacovigilance activities.* Collaboration: Work closely with medical reviewers, safety physicians, and regulatory teams.* Risk Management: Assist in developing and implementing risk minimization plans and safety update reports.* Training & Audits: Participate in internal audits and support training initiatives for pharmacovigilance processes.
EDUCATION
Clariwell Global Services
Diploma in Clinical Research
Dr. Babasaheb Ambedkar Technological University
Bachelor of Pharmacy - BPharm
ABOUT MEGHRAJ KUCHEKAR
Advanced in ARGUS 8.4.0.1 and ARISg with triage, data entry and quality review expertise•Performed case intake and triaged incoming safety information or reports from various sources, whether spontaneous or from clinical trials. •Accurately coded adverse events using MedDRA and assisted in assessing listedness against appropriate labels for marketed products. •Additionally, I assisted in reconciling databases, worked within the Quality Management System framework, and maintained supporting documentation regarding adverse event reporting requirements.*SKILLS*-Proficiency in Oracle Argus Safety Database for case management and processing-Good Pharmacovigilance Practices (GVP)-MedDRA Codding-Follow up of safety case and Generating action item in Argus-Safety signal Management-Scientific literature case processing and triage-Attention to Detail: Strong ability to ensure data accuracy and compliance with safety procedures.
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