Biplab Sikdar

Patient Safety specialist (NIPERian)

Role
Business Process Lead at Tata Consultancy Services
Location
Pune, IN
LinkedIn followers
500 followers

About Biplab Sikdar

Healthcare professional with over 5 years of experience Scientific/Medical writing, PV…

Experience

  1. Business Process Lead

    Tata Consultancy Services

    Feb 2023 — Present · Pune, IN

    Product Quality complaint (PQC) specialist: Management of technical product complaint (TPC/PTC), medical product complaint (MPC) and malfunction reports of pharmaceutical products, medical devices, biologics, diagnostics and combination products. Responding to medical inquiry/complaints for pharmaceutical products/devices from consumer, healthcare professionals and vendors. Reconciliation (quality control activities) of complaints to ensure timely processing and be compliant with regulatory standards. Provide training for handling and processing of product complaints in global safety database (LSMV, Argus). Triage, validation, processing and quality review of malfunction reports, medical and technical complaints cases in safety database. Identification of adverse event or special Situation (TPC+SSR/AE; ICSR) associated with product quality complaints (PQCs). Communicating with complainants, Lead investigator, HCP, Vendor, consumer and other stakeholders.

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Biplab Sikdar — Business Process Lead at Tata Consultancy Services in Pune, IN | Unifers