• Managed case assessment, investigation, documentation, medical research and processing of incoming Adverse Drug Events (ADEs) or Reactions (ADRs).• Reviewed and assessed cases based on expectedness and seriousness compliant with international regulations in a timely manner requirement.• Corresponded with clinical trial coordinator for follow-up queries to ensure completion of patient case details.• Executed data entry and quality review of cases from Literature text, Sponsored and Unsponsored Clinical trials, Spontaneous, and ICSRs into Oracle AWARE Safety Database with emphasis on timeliness, data accuracy, consistency and completeness.• Completed data entry, including collection of domestic ADR information, medical narratives and medical reviewer's comments and instructions with a compliance rate of 100%.• Kept current with drug regulations, revised SOPs and working instructions, and labeling updates.• Expertly handled applications like Aware, MedDra (v 18.0) and WHO browsers.• Imparted training to Pharmacovigilance personnel on regulations, guidelines, ADR case data entry & quality review etc.

• Drafted FTO reports, Preliminary Patent Assessment Reports to scout for possible generic drug options.• Filed patents to ensure product protection.• Drafted office actions leading to successful patent grant outcomes.