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

  1. Senior Process Associate

    Tata Consultancy Services

    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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Yadnyesh Shende — Senior Process Associate at Tata Consultancy Services in Pune, MH, IN | Unifers