Yadnyesh Shende
Pharmacovigilance Scientist-II Quality Reviewer SME-Special Situations TCS WINGS Qualified
- Role
- Senior Process Associate at Tata Consultancy Services
- Location
- Pune, MH, IN
- LinkedIn followers
- 500 followers
About Yadnyesh Shende
Experienced Quality Assurance Apprentice with a demonstrated history of working in the pharmaceuticals industry.
Experience
Senior Process Associate
Oct 2022 — Present · Pune, IN
Tracking all ICSR (individual case safety reports)/adverse event reports received, completing all review and assessment of all the source documents and compiling data in client safety database (ARISg).* Case processing of interventional (clinical trial) and non-interventional study and programs (NIS and NIP) and spontaneous case reports.* Role includes review, extract, and enter AE data from marketed product according to the safety policies, processes and procedures.* Sound knowledge of safety database (ARISg) and MedDRA versions etc.* Good understanding of the principles and concepts associated with patient safety case handling process.* Individual case safety reports (ICSR) initiation in Agxchange DB and end to end case processing in safety database like ARIS-G (7.4)* Information receipt: Handling client mailbox and triaging cases as per case seriousness and timeline.* Initiation of a case: Creation of a new case form a source document, performing effective duplicate.
Education
Savitribai Phule Pune University
M.Pharmacy
2019
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