Sankalp Hampimath
Drug Safety Associate @IQVIA
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WORK HISTORY
Drug Safety Associate @IQVIA
Processed ICSRs from multiple sources (spontaneous, clinical trials, PSPs, post-marketing) in compliance with international PV regulations (ICH, CIOMS), client SOPs, and local health authority requirements.• Performed medical and drug coding using MedDRA and WHO-DD per client guidelines.• Conducted duplicate checks, causality and seriousness assessments, and case validity reviews.• Drafted and reviewed case narratives for clarity and medical significance.• Participated in team training initiatives and knowledge-sharing sessions.• Monitored case prioritization based on regulatory due dates, safety significance, and turnaround targets.• Resolved case-related issues through consultation with medical reviewers and team leads, escalating complex cases as required.• Analyzed and discussed safety information across multiple therapeutic areas.• Worked independently and met targeted timelines in a team-centric environment.• Managed receipt and processing of spontaneous and solicited adverse event reports, including clinical trial cases.• Performed accurate data entry of safety data into adverse event databases and tracking systems.• Reviewed adverse events for completeness, accuracy, and appropriateness for expedited reporting.• Determined listedness against appropriate product labels for marketed products.• Identified clinically significant missing information and prepared follow-up correspondence in coordination with medical staff.• Ensured cases received appropriate medical review prior to submission.• Ensured expedited reporting to global regulatory authorities and other stakeholders within required timelines.
EDUCATION
Government College of Pharmacy
Bachelor of Pharmacy
Rajiv Gandhi University of Health Sciences
Bachelor of Pharmacy - BPharm, Healthcare
ABOUT SANKALP HAMPIMATH
IQVIA India benefits from contributions as a Drug Safety Associate, focusing on pharmacovigilance and compliance to support healthcare initiatives. Leveraging a Bachelor of Pharmacy degree from Rajiv Gandhi University of Health Sciences, the role emphasizes ensuring drug safety and regulatory adherence. Past experience as a Safety Associate Trainee at the same organization reinforces a strong foundation in data analysis and healthcare processes. Dedicated to advancing patient safety through systematic evaluation and collaborative workflows.
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