Biplab Sikdar

Medical Device Safety and product quality Complaint (PQC) Handling professional with 6+ years of experience across pharmacovigilance and medical device safety operations. Experienced in product quality complaint management, technical/product complaint handling, malfunction report processing, adverse event identification, case triage, follow-up, reconciliation, quality review, and regulatory-compliant safety reporting. Experienced in managing complaint-related cases involving medical devices, diagnostics, biologics, pharmaceutical products, and combination products.

Strong expertise in complaint assessment, documentation, data quality, stakeholder communication, and safety database operations, with hands-on experience in LSMV and ArisG.

Business process lead at TCS (2023-02 – Present)

• Manage end-to-end processing of medical device, technical product, pharmaceutical product, biologic, diagnostic, and combination-product complaints, including complaint review, triage, validation, processing, documentation, and quality review.
• Perform product quality complaint (PQC) and malfunction report assessment, ensuring accurate capture, evaluation, and processing of complaint information in accordance with applicable procedures and regulatory requirements.
• Conduct complaint triage and validation to identify potential adverse events, special situations, product quality issues, and reportable safety information associated with complaints.
• Identify and assess adverse events associated with product quality complaints (PQC + AE/ICSR) and ensure appropriate routing and processing within the applicable safety workflow.
• Perform quality control and reconciliation activities for complaint records to ensure completeness, accuracy, consistency, timely processing, and compliance with established quality requirements.
• Process and quality-review medical and technical complaint/malfunction cases within global safety databases, including LSMV and ArisG.
• Perform follow-up and communicate with complainants, healthcare professionals, consumers, vendors, lead investigators, and other stakeholders to obtain and clarify relevant complaint information.
• Develop standardized, customer-focused responses to medical and product-related inquiries received from healthcare professionals, consumers, vendors, legal teams, and third-party manufacturers.

Freelance Medical Writer at Ichelon Consulting Group (2025-08 – Present)

• Literature Review Development: Conducted comprehensive literature reviews and synthesized complex clinical data into structured, publication-ready articles.
• Visual Data Communication: Developed infographics and graphical abstracts to effectively communicate complex scientific concepts.

Drug safety associate at Qinecsa (2022-03 – 2023-02)

• Supported quality management activities through RCA and CAPA development, quality review, process feedback, and training.
• Performed detailed case quality review and data verification to ensure completeness, consistency and accuracy. Responding to queries from client, licensing partner and internal team.
• ICSR processing including case validation, data entry in ArisG for all types of cases (Literature, spontaneous, HA, clinical trial cases, etc.)
• Processing of special situation reports such as Misuse, Medication error, user error, off-label use and pregnancy reports.
• Adverse event coding using MedDRA, Seriousness determination of events, labeling assessment as per country of occurrence and reporter causality assessment.
• Suspect product coding as per CPD and capturing of drug approval number based on formulation and country of occurrence, other company product coding using WHO DD.

Safety Analyst at WIPRO (2021-09 – 2022-03)

Same role as in Springer nature, as ADIS PV project was taken over by Wipro from springer. Thus, worked in same role/project in these two different organizations.

Junior Scientific and Medical Writer at Springer nature (2020-05 – 2021-08)

• Translate clinical and scientific data from published the biomedical literature into clear, accurate and engaging content for publication.
• Write the accurate and concise summaries of pharmaceutical product that capture the key elements of the medical literature reports (safety newsletters).
• Literature ICSR processing and performing quality review of ICSR.
• Reviewing the published reports/biomedical literature to validate the ICSR criteria and Reporter causality for event.
• Performing data entry in the safety data base from literature article such as event identification, Seriousness determination and MedDRA coding of adverse events.
• Safety case narrative writing for single or multi-patient in chronological order of the events with outcomes.

M.S. Pharmacy in Regulatory Toxicology – NIPER- Raebareli (2020)

Bachelor of pharmacy – Pune University (2018)

HSC – Nagpur Board (2014)

SSC – Nagpur Board (2012)