Nilesh Bhamare
Senior Drug Safety Associate @EVERSANA
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WORK HISTORY
Senior Drug Safety Associate @EVERSANA
Pune, IN
End-to-end pharmacovigilance activities handled, including AE and SAE triage, ICSR processing, MedDRA and WHODRUG coding, narrative writing, and regulatory submissions in compliance with global PV regulations. Extensive work performed on client safety databases such as Argus/ARISg, ensuring high data quality, consistency, and adherence to SLA timelines. Quality control reviews conducted, follow-up queries coordinated, aggregate reporting activities assisted, and periodic SAE reconciliations completed. Contribution made toward mentoring junior team members, onboarding, cross-functional collaboration, process improvement initiatives, and audit readiness.
EDUCATION
Kvps Institute of Pharmaceutical Education
Bachelor of Pharmacy - BPharm, Pharmacy
ABOUT NILESH BHAMARE
Detail-oriented Pharmacovigilance professional with 8+ years of experience across global CROs and life-sciences organizations, specializing in end-to-end ICSR processing, SAE management, regulatory submissions, and quality compliance. Hands-on expertise in AE/SAE triage, MedDRA and WHODRUG coding, narrative writing, safety database management (Argus/ARISg), and global regulatory reporting in alignment with ICH and health authority requirements. Proven ability to manage complex case lifecycles while consistently meeting SLA timelines and audit-ready quality standards. Recognized for strong analytical skills, attention to detail, and the ability to mentor junior associates, support process improvements, and collaborate effectively with cross-functional stakeholders. Passionate about patient safety, compliance excellence, and continuous improvement in pharmacovigilance operations. Let’s connect or reach me at n••••••••@gmail.com Top 5 Skills : Pharmacovigilance & Drug Safety Operations | ICSR & SAE Case Processing | Regulatory Reporting & Compliance | MedDRA & WHODRUG Coding | Safety Database Management (Argus / ARISg)
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