Souvik H
Drug Safety Associate-II at Novo Nordisk || Process Trainer || SME Medical Devices & Pregnancy || Signal Detection || Signal Management || MedDRA || MDR ||NextGen Safety Surveillance || Rare Disease || M.Pharm ||
- Role
- Drug Safety Associate-ii at Novo Nordisk
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Souvik H
I’m a Pharmacovigilance professional Passionate about advancing patient safety aiming to contribute to shaping the future of global PV with 4.6 years of experience in Safety Operations, Materiovigilance, and stakeholder management. My key responsibilities include training, audit and inspection readiness, SOP review, DCR monitoring, reconciliation of medical device and pregnancy cases, and serving as POC during the GPS transition from ARGUS to Veeva Safety.I bring expertise in triage, QC, verification, and processing of non-serious and serious PM cases, acting as SME for haemophilia, pregnancy, medical device, regulatory authority, PumpCart cases, and supporting partner areas such as IQVIA-EVERSANA, legal cases, spon. cases detected in CT, and NIS cases from EDC. I successfully manage task allocation, workflow optimization and resource distribution, ensuring operational excellence.Knowledge Transfer pivot—I’ve trained Global Safe-Op Advisers, Specialists, case handlers, QC reviewers, managers, and new-hires on pregnancy and medical device case handling, while mentoring colleagues through RCA of TLE/AMR. Currently, I’m contributing as a role model for the Learn from Your Peers (LEAP) initiative, creating interactive content to drive career growth and competency development. My contributions toward building strong rapport with cross-functional teams have been instrumental in monitoring SUSARS in close collaboration with affiliates and other partners.Beyond case management, I’ve led process improvements, DCRs, and simplification by challenging status quo, enhanced audit readiness, NGS data migration clean-up, Flowchart preparation, DOB Review, Manual QC, Narrative Review, driving monthly caseman meets, Affiliate Support and cross-functional collaboration.I hold D.Pharm, B.Pharm & M.Pharm in Pharmacology from Maulana Abul Kalam Azad University of Technology, Kolkata, along with certification in Advanced Diploma in Computer Applications (Govt. of India). I’ve completed LinkedIn certifications in AI, Project Management, Training, and Digital Transformation.Recognized as a consistent top performer, I’ve earned the Department GEM Award for 8 consecutive quarters, Dream Team Award, Global Safety Premier League Champion title, and PV Academy hosting honors. My strengths include teamwork, people management, communication, analytical skills, adaptability, and professional accountability.My areas of interest include PV, People Management, Project Management, Training, NextGen Safety, PMS, Signal Monitoring, and Clinical Research.
Experience
Drug Safety Associate-ii
Sep 2023 — Present · Bengaluru, IN
Audit & inspection readiness, SOP review, DCR monitoring• Reconciliation of medical device & pregnancy cases; SME for haemophilia, pregnancy, medical device & regulatory authority cases• Training & mentoring global teams; contributor to LEAP initiative for peer learning & competency growth• Point of Contact for GPS transition (ARGUS → Veeva Safety)• Workflow optimization, task allocation & resource management
Education
Maulana Abul Kalam Azad University of Technology, West Bengal formerly WBUT
Bachelor of Pharmacy - BPharm, Pharmaceutical Technology
West Bengal State Council of Technical & Vocational Education and Skill Development (WBSCT&VE&SD)
D.Pharm, Diploma in Pharmacy
Maulana Abul Kalam Azad University of Technology, West Bengal formerly WBUT
M.Pharm, Master of Pharmacy in Pharmacology
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