
Kaustubh Kandharkar
Pharmaceutical / Bio-tech
Services offered
I have the Pharmacovigilance knowledge and experience to qualify for this position and I am confident that I can be an asset to your company.
I have completed M. Pharmacy in Quality Assurance and over 7 years of experience in the Pharmacovigilance and Life Science industry.
Experience
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
Education
M. Pharmacy in Quality assurance
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