Ashutosh Sharma
M. Pharm, RPh, PGDCR, CSSE-GB\\n\\nPV Professional- Aggregate Reporting
- Role
- Pv Professional-aggregate Reporting at Teva Pharmaceuticals
- Location
- Bengaluru, IN
- LinkedIn followers
- 500 followers
About Ashutosh Sharma
Masters in Pharmacy (Pharmacology and Toxicology), Postgraduate Diploma in Clinical Research and Pharmacovigilance, and Six Sigma Green Belt certified. Inquisitive and eager to advance my career in Drug Safety and Patient Wellbeing. Proficient in ICSR processing (logging, data entry, labeling, manual coding, narrative writing) and quality review for spontaneous, line listing, LP, MC, and CT cases. Skilled in initial evaluation of adverse events (serious and non-serious), raising and handling case-specific queries, conducting Quality Huddles, and full narrative writing for various case types (C-SUSAR, C-SSAR, NIS/PMS, LP). Experienced with databases: Sapphire, Safety Easy (AB Cube), Aris g, and Veeva V-safe. I actively seek new learning opportunities, focusing on signal detection, aggregate reporting, and Risk Management Plans (RMP), applying a stepwise approach for continuous improvement.
Experience
Pv Professional-aggregate Reporting
Jan 2023 — Present · Bengaluru, IN
Data collection, authoring, and preparation of selected PSUR sections for Generics and Branded products.Review and QC of PSUR sections.PSUR finalization and creation of PDF.Drafting responses to regulatory agency requests.Ensuring PSUR-related activities comply with procedures.Data generation for PADER and LATAM report preparation.
Education
Faculty of Management Studies, Gurukul Kangari University
Bachelor of Pharmacy
2013 — 2017
JSS University (Jagadguru Sri Shivarathreeshwara University),Mysore
Master in pharmacy
2018 — 2020
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