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
Business Process Lead
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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