Shanmugapriya Nehrukumar
Senior Drug Safety Scientist @Accenture
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WORK HISTORY
Senior Drug Safety Scientist @Accenture
Chennai, IN
Processed end-to-end ICSRs (Individual Case Safety Reports) – Spontaneous, Literature, Legal, Social Media, PatientRegistries, Poison control centres, Interventional clinical trial, CUPs, PSPs, PAPs, PMSSs, MRPs, MICCs and HealthAuthority Downloads aligned with global regulatory requirements.• Conducted MedDRA/WHO-DD coding, seriousness determination & causality assessments, narrative authoring andfollow-up query management.• Performed inline QC of peer cases, ensuring high accuracy and compliance before final submission.• Led Training and mentoring new joiners and MAT returning staff; developed quick-start guides and SOPwalkthrough sessions.• Coordinated ICSR reconciliation activities between safety database and regulatory/clinical systems to maintain dataintegrity.• Participated in UAT, smoke and regression testing during safety system upgrades (LSMV and NavaX), validatingcritical functionalities and workflows.• Acted as point-of-contact for case-related quality issues; reduced query rate by 25%.• Delivered internal training sessions on safety database migration from Argus to LSMV.• Contributed to audit readiness and successfully supported internal and two health authority inspections with zerocritical findings.• Collaborated with PV managers on resource planning, team development, training calendars, and workloadallocation.
EDUCATION
Vel's Institute of Science, Technoloy and Advanced Studies, Chennai
Bachelor of Pharmacy - BPharm
ABOUT SHANMUGAPRIYA NEHRUKUMAR
Pharmacovigilance professional with over 7 years of comprehensive experience in end-to-end ICSR processing across spontaneous, literature, clinical trial, and regulatory sources. I specialize in ensuring global regulatory compliance (MHRA, EMA, FDA) through meticulous safety case processing, MedDRA/WHODD coding, narrative writing, and rigorous quality control.Skilled in utilizing leading safety databases (Argus, ArisGlobal, LSMV, NavaX) and data exchange systems, I bring a proven track record of supporting audits and inspections with zero critical findings. My expertise also extends to regression/smoke testing, UAT, and safety database migrations.Beyond technical execution, I’m deeply committed to team development—having trained and mentored new joiners, authored SOP walkthroughs, and collaborated on resource planning with PV leadership. Recognized with multiple performance awards and selected for emerging leadership programs, I thrive in roles that blend operational excellence with collaborative leadership.Let’s connect if you’re passionate about driving safety, compliance, and continuous improvement in the pharmacovigilance space.
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