Naveen Tanwar

About Naveen Tanwar

Passionate, committed and diligent individual with Masters in Pharmacy and sound knowledge of Pharmacovigilance concepts, ICH guidelines, Case Triage, Narrative writing, performing Labeling/ Listedness and Causality determination. Practical hands on experience on ARISg Safety 5.0 including initial Case entry, Duplicacy check, and complete case entries. Well versed with MedDRA 18.0 and WHO Drug Dictionary coding during case processing. Good knowledge of Drug Development Process including Drug safety and different Phases of Clinical Trials and basic understanding of regulatory requirements for clinical research and Pharmacovigilance. Academic research in molecular biology with hands on experience in DNA/RNA isolation and gel electrophoresis, RT-PCR, ELISA, Immunohistochemistry, Histology, fluorescent staining and animal handling.

Experience

1. Senior Research Scientist

   SUN PHARMA

   Dec 2017 — Present · Gurgaon, IN

   Case triage- Assess seriousness, expectedness.Case processing- Duplicacy check, case entry, MedDRA coding and narrative writing of ICSRs received from literature, Clinical trial (study), regulatory authorities (ASPRs), CIOMS and ICHE2B (AgExchange). Case follow up and update- Patient/reporter follow up and case update as per latest receipt date on which the updated information was received. Case tracking: Through entries in case activity tracker (CAT).

Education

• Himachal Pradesh University

  Bachelor of Pharmacy

  2007 — 2011

• JP University of Information Technology

  Master of Pharmacy

  2012 — 2014

Skills

• Drug Safety
• Regulatory Affairs
• Case Triage
• Medical Coding
• Pharmacovigilance
• Causality Assesment
• Case Studies
• Research
• Psur
• Clinical Studies
• Microsoft Office
• Adr Reporting
• Life Sciences
• Organic Synthesis
• Hplc
• Medicinal Chemistry
• Medical Writing
• Meddra
• Pharmaceutical Industry
• Case Narrative Writing