More than 2 years of experience in PV and Gaining Knowledge in Pharmacovigilance (PV) activities including Medical review of Individual Case Safety Reports (ICSRs). Aiding for cases from a medical perspective to PV Scientists who participate in processing ICSRs, assessing events for coding, MedDRA (Medical Dictionary for Regulatory Activities) coding of adverse events
Overview
5
5
years of professional experience
1
1
Certification
Work History
Drug Safety Physician
Parexel International Services India Private Limited
11.2021 - Current
Provide medical inputs in processing of Individual Case Safety Reports (ICSRs), carrying out the review of Designated Medical Events (DMEs)and to identify events of special interest, perform medical review of individual case Safety reports of all case types including literature, non-literature cases.
perform Analysis of seriousness of events based on medical assessment, perform Causality assessment of Individual Case Safety Reports (ICSRs) based on excellent medical knowledge and causality assessment criteria
Gaining knowledge of Corrective and preventive action (CAPA) and performing root cause analysis, perform quality review and checking cases for discrepancies for any errors relatedly labeling and narrative writing, Getting accustomed with typical tools used in Pharmacovigilance.
prioritizing and maintain timelines as per client and Regulatory requirements, Maintaining consistency of safety assessment.
MedDRA coding in accordance with “MedDRA Term Selection.
Maintaining good working knowledge of the safety profile of assigned drugs, Reference Safety Information documents,guidelines, clients’ procedures, and international drug safety regulations.
Awareness about ethical guidelines for human and animal trials.
Junior Medical Officer
Purnas Remedy Hospital
Tirupati
03.2019 - 10.2021
Experienced in supporting senior physicians and managing cases across diverse medical units, including Intensive Care, Acute Medical Care, Pediatrics, Obstetrics and Gynecology, and Acute Surgical Care. Proficient in collaborative efforts, having successfully worked with 15 interns, 2 Postgraduates, 1 Assistant Professor, and 1 Professor. Averaged daily handling of 30 to 40 medical cases, showcasing competence in a dynamic healthcare environment.
Medical Camp Physician
Medical camp by Purnas Remedy Hospital.
01.2019 - 02.2019
Oversaw medical emergencies, operated in both in-patient and out-patient departments, and conducted comprehensive reviews and approvals of case files.
Education
Physician. Doctor of Medicine (M.D.) -
Uzhhorod National Medical University
Ukraine
Skills
Argus safety
MEDDRA
ICSR
Regulatory Compliance
Data Evaluation
Research and Development
Report Writing
Project Management
Quality Control
Good Clinical Practice
Patient Safety
MS Office
Certification
Medical Registration certificate to practise medicine in India, from Andhra Pradesh Medical Council of India.
license to practise medicine in Ukraine.
Affiliations
Mentorship: Guided new hires for a positive onboarding.
Volunteer: Contributed to medical camps on weekends.
Drug Safety Physician at Parexel International Services India Private LimitedDrug Safety Physician at Parexel International Services India Private Limited
Drug Safety Specialist at PAREXEL International Services India Private LimitedDrug Safety Specialist at PAREXEL International Services India Private Limited
Manager, PV Operations at Parexel International Services India Private Limited, MohaliManager, PV Operations at Parexel International Services India Private Limited, Mohali
Drug Safety Associate II at Parexel International Services India Private LimitedDrug Safety Associate II at Parexel International Services India Private Limited