Santosh Naiknaware

About Santosh Naiknaware

Experienced pharmacovigilance professional with a Bachelor of Pharmacy degree from Pune…

Experience

1. Senior Executive

   Wipro

   Oct 2023 — Present · Pune, IN

   Literature Case processing Reviewed published reports and biomedical literature to identify individual casesafety reports (ICSRs) and non-individual case reports.Assessed each article based on regulatory and internal guidance to determine casevalidity.Applied MedDRA coding and WHO Drug Dictionary (WHO-DD) for accurate entry ofmedical history, concomitant drugs, and adverse events (AEs).Composed accurate, medically sound narrative summaries reflecting key clinical dataand safety signals.Created safety content in various formats such as narrative summaries, structureddatabase fields, and electronic formats for regulatory filing.Ensured consistency and completeness in data extraction and entry to supportregulatory submissions and pharma industry reporting standards.Applied coding conventions and terminology standards to maintain data uniformityacross cases.Participated in additional responsibilities assigned by team leads/managers relatedto literature evaluation and case handling.2. Quality Reviewer ResponsibilitiesEvaluated Serious Adverse Events (SAEs) from source documents with focus on dataaccuracy, regulatory compliance, and timeliness.Conducted quality checks to ensure accurate processing of safety information fromliterature sources.Ensured consistent coding of medical history, drugs, and adverse events, aligningwith case definitions and regulatory expectations.Performed secondary reviews of narratives and data entries, validating thecompleteness, accuracy, and quality of the reported information.Acted as quality gatekeeper for literature-based ICSRs submitted for downstream regulatory activities

Education

• Rajgad dyanpeeth collage of pharmacy bhor,pune

  Diploma

  2015 — 2017

• Marathwada mitra mandal college of pharmacy

  Bachelor of Pharmacy

  2016 — 2020