Abinash

About Abinash

As a dedicated healthcare professional with a strong foundation in both clinical pharmacy and pharmacovigilance, I bring hands-on experience in ensuring patient safety and regulatory compliance across critical therapeutic areas including Oncology, Cardiology, and Antibiotics.At Accenture, I worked as a Pharmacovigilance Services Associate, where I was responsible for processing and reviewing Individual Case Safety Reports (ICSRs), medical coding using MedDRA & WHO-DD, and ensuring timely regulatory submissions in line with global pharmacovigilance guidelines (ICH-GCP, GVP, FDA, EMA).Before that, I served as a Clinical Pharmacist at SIMS Hospital (SRM Institutes for Medical Science), where I actively participated in clinical ward rounds, prescription audits, Antibiotic Stewardship, Chemo Admixture, Chemotherapy Protocol Management, adverse drug reaction (ADR) monitoring, and patient counseling, contributing to rational and safe medication practices.Key Expertise- Pharmacovigilance & Drug Safety (ICSRs, PSURs, Signal Detection)- Clinical Pharmacy & Patient Care- Therapeutic Knowledge: Oncology, Cardiology, Antibiotics- Regulatory Compliance (ICH-GCP, GVP, FDA, EMA)- Medical Coding (MedDRA, WHO-DD)- Narrative Writing & Causality AssessmentI am passionate about leveraging my clinical knowledge and safety expertise to contribute meaningfully in Medical Affairs, Regulatory Affairs, or as a future Medical Science Liaison (MSL). I\'m open to opportunities where I can further grow and support healthcare innovation with scientific and regulatory excellence.Let’s connect if you’re looking for a motivated and adaptable healthcare professional ready to make a positive impact in global drug safety and medical affairs.

Experience

1. Drug Safety Associate

   Accenture

   Dec 2025 — Present · Chennai, IN

   Performing end-to-end ICSR case processing (Initial and Follow-up cases) in ArisGlobal / LifeSphere Safety (LSMV) in compliance with global regulatory standards (Phase4/Spontaneous, Clinical Trials, Medical Devices, Literature)Conducted case triage, data entry, narrative writing, and quality review to ensure completeness, accuracy, and compliance with company SOPs and client-specific guidelines.MedDRA coding for adverse events, indications, and medical history, suspect and concomitant medications.Performed validity, seriousness, and causality assessments following standard pharmacovigilance practices.Ensured regulatory compliance with EMA, FDA, and ICH-GCP requirements and timelines.Executed duplicate checks, follow-up requests, and case reconciliation activities to support case quality and database integrity.Collaborated effectively with global safety teams and contributed to process improvement initiatives to enhance case processing efficiency and quality.

Education

• VELS University

  Doctor of Pharmacy - PharmD, Pharmacology

• SRM Institute of Science and Technology (SRMIST)

  Master of Business Administration - MBA, Health/Health Care Administration/Management