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Kiran Kumar

@kirankumar25

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Medical device vigilance specialist at 4C Drug Safety Services handling global complaint reporting.

India

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What I'm looking for

I'm seeking a challenging role in a reputable organization where I can apply my technical, database, and management expertise, contribute to organizational growth, and expand my knowledge of emerging trends in medical devices and healthcare.

At 4C Drug Safety Services, I handle medical device complaints from intake and evaluation through investigation, vigilance reporting, and closure. I assess MDR/eMDR and vigilance reportability and submit reports to the US FDA, EU Authorized Representatives, and Health Canada.

I review medical device complaints at Alcon Laboratories India Pvt Ltd, including serious adverse events, technical investigations, and malfunction cases. I also perform event and IMDRF coding and summarize investigation findings.

At Bioclinica Pvt Ltd, I processed ICSR cases, assessed adverse event data, and wrote case narratives using clinical source documents. I hold a Master of Pharmacy and have experience with post-market surveillance, pharmacovigilance, and regulatory compliance.

Experience

Work history, roles, and key accomplishments

Current

Associate Team Lead

Current

4C Drug Safety Services

Dec 2022 - Present (3 years 10 months)

Handled customer complaints including intake, evaluation, investigation, vigilance reporting, and closure. Reviewed and classified medical device complaints, assessed MDR/eMDR and Vigilance reportability, and generated regulatory reports to FDA, EU Authorized Representatives, and Health Canada.

Complaint Handling EMDR Vigilance Reporting Adverse Event Reporting Trend Analysis Quality Metrics Trackwise CATSWEB Salesforce SAP LifeSphere MultiVigilance Argus Safety E Submitter Microsoft Office

Patient Safety Specialist

Alcon Laboratories India Pvt Ltd

Feb 2020 - Dec 2022 (2 years 10 months)

Handled serious adverse events, technical investigations, malfunction cases, and escalations for medical devices. Performed complaint evaluations, event coding, IMDRF coding updates, and collaborated with QA, Investigation, and Regulatory Affairs teams.

Adverse Event Handling Technical Investigation Complaint Evaluation IMDRF Coding Event Coding Problem Classification Regulatory Affairs QA Collaboration

Senior Drug Safety Associate

Bioclinica Pvt Ltd

Nov 2016 - Feb 2020 (3 years 3 months)

Managed end-to-end processing of Individual Case Safety Reports (ICSRs) including intake, triage, data entry, clinical assessment, follow-up, and closure. Applied MedDRA coding, wrote case narratives, and ensured regulatory compliance with pharmacovigilance SOPs.

ICSR Case Processing Adverse Event Analysis MedDRA Coding Case Narrative Case Processing Document Review Quality Control Regulatory Compliance Pharmacovigilance Data Reconciliation

Education

Degrees, certifications, and relevant coursework

Raghavendra Institute of Pharmaceutical Education & Research (RIPER)

Master of Pharmacy, Pharmacy

Grade: First Class (85%)

Master of Pharmacy degree from Raghavendra Institute of Pharmaceutical Education & Research, affiliated with JNTU Anantapur, completed in October 2014 with first class and 85% marks.