Mrunmayi Pokharkar
Drug Safety Executive
Pune
Summary
Results-driven pharmacovigilance professional with experience in managing operations, specializing in ARGUS database management and literature triage. Proficient in conducting Embase searches and overseeing ICSR/non-ICSR aggregate reviews. Proven ability to execute comprehensive journal reviews for subsidiaries, ensuring compliance and accuracy.
Overview
3
3
years of professional experience
Work History
Drug Safety Executive
Fidelity Health Services (For Lupin Ltd.)
Mumbai
05.2024 - Current
- Hands-on experience with the ARGUS database.
- Literature Review and Triage: MLM, Early Alert of E2B Cases, and E2B Cases.
- Executed literature search strings on the Embase database.
- Managed ICSR activity and non-ICSR aggregate review.
- Annexure update of newly added drug molecules for global and local literature, based on the company product list.
- Annual review of journals with Lupin subsidiaries for local literature monitoring.
- Mentoring newly-joined associates.
- Preparation of the MOM.
Research Associate
Lupin Ltd
Pune
10.2021 - 04.2024
- Responsible for preparing Standard Test Procedures (STPs) and specifications of various dosage forms, i.e., OSD, injectables, and ophthalmic.
- Responsible for the review of JOS and the specification.
- Documentation Control: Handling Document Management System (DMS), OmniDocs, and issuance and archival activities.
- Responsible for performing the calibration of analytical instruments, such as the pH meter, Balance (daily calibration as well as parameters like repeatability, eccentricity, and linearity), Sonicator, Water Bath, Vacuum Oven, Dissolution apparatus (VPM and PVT), and HPLC.
- Handling breakdowns of analytical instruments and maintenance.
- Handling change controls and deviations through QAMS.
Education
Master of Pharmacy (M. Pharm) -
AISSMS College of Pharmacy
Pune, India06-2021
Bachelor of Pharmacy (B. Pharm) -
Dr. D.Y.Patil Institute of Pharmaceutical Science
Pune, India06-2019
Skills
- Technical Skills: Adverse Event Reporting, Safety Database Management, Regulatory Compliance,
- Analytical skills: Data analysis of safety, root cause analysis for safety issues
- Software Skills: Argus, FileZilla, OmniDocs, DMS, QAMS, Microsoft Office
Accomplishments
- Lupin Value Ranger (May 2023)
- Dissolution PVT: Instead of vendor, GLP team is taking care of it
- Excipient development with at hand instruments and readily available chemicals
Achieved by cost cutting in
PUBLICATIONS
- Damle M, Pokharkar M, Kapratvar P. A Stability Indicating HPTLC Method for Pazopanib. Research Journal of Pharmaceutical Dosage Forms and Technology. 2024 Aug 7;16(3):210-4.
- Damle M, Pokharkar M, Pharm MS, Pharm RP. Lifestyle Disorder-Risk Factors, Lifestyle Modification. NOVYI MIR. 2021 Jun 1;6(6):199-208.
- Pokharkar M, Damle M, "Survey: Consumer Perceptions Towards Medicines Types: Brand Medicines Versus Generic Medicines.", IJRAR - International Journal of Research and Analytical Reviews (IJRAR), E-ISSN 2348-1269, P- ISSN 2349-5138, Volume.8, Issue 2, Page No pp.943-952, April 2021
COURSES
- Completed Personality Development program organized by Mahindra Pride classes.
- Completed Quality by Design (QbD) course organized by Dr. D.Y.Patil Institute of Pharmaceutical Science, Pimpri, Pune.
- Completed Technology Transfer Bridge Course organized by OpEx Accelerator Pvt. Ltd
Reference
Dr. Kishore Sonkusare
Associate Director
Lupin Limited, Pune
+91 9377756436
Timeline
Drug Safety Executive
Fidelity Health Services (For Lupin Ltd.)
05.2024 - Current
Research Associate
Lupin Ltd
10.2021 - 04.2024
Master of Pharmacy (M. Pharm) -
AISSMS College of Pharmacy
Bachelor of Pharmacy (B. Pharm) -
Dr. D.Y.Patil Institute of Pharmaceutical Science
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