Kiran Pawar
Lead Safety Science Specialist | CAPA, Audit| Process Improvement | Pharmacovigilance Scientist /Drug Safety/Aggregate writing/PSUR| PBRER
- Role
- Lead Safety Science Specialist at Labcorp
- Location
- Pune, MH, IN
- LinkedIn followers
- 500 followers
About Kiran Pawar
Total more than 8.10 years of experience in core pharmacovigilance domain and global product complaint Management with a demonstrated history of working in the pharmaceuticals, Life Science industries and clinical research industry. Skilled in Medical literature review, European Medicines Agency Medical Literature Monitoring, ICSR, Retrospective Quality Review and Vendor Quality Management activities. • Team handling, Team productivity & quality management, database atomization, process improvement activity. • Trainings: Trainer & Subject Matter Expert (SME), Evaluates and identifies staff training needs to ensure all personnel are trained within the team, and responsible for oversight of training compliance of direct reports.• PV Audits: Leading internal, client, Business partner & regulatory Audits (MHRA, FDA), for pre-Audit preparation, provided online documentary evidences & performed other audit re-lated activities. To ensure the project Audit readiness and publish audit readiness scores with higher management.• Experience in end to end Pharmacovigilance Database automation, strategy development, testing database, give feedback, process improvement idea to developers team to configure database to improve quality, productivity of project.• Receipt and handling of product quality complaints, trending and reporting of global product quality complaint or Adverse Event Quality Investigation reporting. • End to end CAPA handling, identify root cause analysis for any defects, error in PV system database & provide input on atomization on it. Involve in preparation for internal, client & regulatory Audits.• Strong professional with a Master of Pharmacy focused in Pharmaceutics from University of Pune
Experience
Lead Safety Science Specialist
Nov 2017 — Present · Pune, IN
Education
PES’s Modern College of Pharmacy, Pune
Bachelor of Pharmacy - BPharm
2008 — 2012
Sinhgad Technical Education Society’s SKNCOP, Pune
Master of Pharmacy
2013 — 2014
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