Kaustubh Kandharkar

Provided dedicated support on Medical Information/Drug Safety aspects of the ICSR and Literature case process and collaborated with other functional areas of the organisation. Maintains, understanding and compliance with SOPs, Work Instructions (WIs), global

drug/biologic/device regulations, GCPs, ICH guidelines, GVP, project/program plans and the drug development process.

• Resolved preventable issues with drug safety database by working with IT Department, which decreased the audit time by 40%.

Reduced safety profile writing time by 33% by standardising the process.

• Collaborated with international affiliates to ensure accuracy and completion of drug safety reports.

• Managed daily workload for signal, literature searches, aggregate reports generation and any other tasks relevant to the Pharmacovigilance Department.

• Developed and maintained safety-related documents for regulatory submissions.

• Established continuous processes and procedures to ensure compliance with applicable regulations and client standards.

Successfully analysed and reported on safety data for adverse event trends and safety signals.

• Managed a process re-engineering project to improve and consolidate end-to-end service processes; restructured communication flow among

• Training and mentoring of new employee team in pharmacovigilance.

• Provides mentoring and work direction to more junior level staff.

• Analyses, reviews, and interprets safety data, both non-clinical and clinical and any other relevant sources

• Authoring and review of Aggregate reports (PSURs/PBRERs, PADERs/Annual Reports/ ACO/ DSUR) for

submission to local and other Health Authorities

M. Pharmacy in Quality assurance