Experience

Clinexel Life Sciences Pvt Ltd

• India
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Executive - Pharmacovigilance

  • Jan 2023 - Present



Cognizant technology solution

• Navi Mumbai, Maharashtra, India

• Senior Drug Safety Associate

  • Aug 2019 - Apr 2022

  ● Handled Quality reviewer’s position in which performing quality check of ICSRs processed by case processor for accuracy and completeness. Performing medical cohesiveness check in which accuracy and completeness of case and safety narrative for its medical sense is checked. ● Hands-on experience in end to end ICSR case processing of spontaneous, Post marketing surveillance, and Literature cases. ● Thorough knowledge regarding drug and event coding using MedDRA and WHO-DD dictionaries. ● Adverse event labeling with the use of labeling documents such as Investigators Brochure (IB), CCDS, EU-SmPC and US Package Inserts. ● Safety narrative writing to summarize ICSR. ● Experience in working on Pharmacovigilance safety database ARGUS. ● Understanding the principles and concepts associated with Patient Safety case-handling process including regulatory requirements and maintained top notch quality and compliance throughout the career. ● Identify and record ICSR quality issues. Do a root cause of errors (RCA) and understand and implement the corrections required for cases (CAPA). ● Mentor fellow team members and new staff members. ● Drive and maintain quality standards for various client deliverables across the team. Show less



Tata Consultancy Services

• India
• IT Services and IT Consulting
• 700 & Above Employee

• Senior Process Associate

  • Aug 2016 - Jul 2019

  ● Experience in acceptance and assessment of medical documents in safety database for adverse events, Triage and Book-in of ICSR. ● Strong experience in end to end ICSR case processing of spontaneous, Post marketing surveillance, and Literature cases. ● Eloquent narrative writing to summaries case details as per regulatory requirements. ● Experience in working on Pharmacovigilance safety databases ARGUS, ARISg, AgXchange and project specific tools for acceptance of source documents. ● Mentor fellow team members and new staff members through presentations and training. ● Compilation and maintenance of qualitative and quantitative data throughout the team for various aspects. ● Plan and implement team building activities to drive associate's performance to maintain healthy work culture. Show less