Souvik H

Pharmacovigilance professional nearing 5 years of experience in Global Drug Safety Operations across case processing, quality control, and regulatory compliance. Proven expertise in ICSR processing, signal detection support, aggregate safety data handling, and benefit-risk evaluation support. Experienced in Argus and Veeva Safety, with strong exposure to FDA, EMA, MHRA, ICH-GVP, E2B, and CIOMS guidelines.

Recognized SME in complex case handling (pregnancy, medical device, literature) with a track record of improving case quality, compliance, and workflow efficiency.

Drug Safety Associate II - Novo Nordisk

(2023-09)

• Perform end-to-end ICSR processing (150–600 cases /month) including triage, data entry, medical coding, and Peer Review through Quality Control
• Conduct seriousness, causality, and expectedness assessments ensuring global regulatory compliance
• Handle complex safety cases including NIS cases from EDC, literature, PQCs, Medical Durable Device Incident & Dr-Dv Combination cases
• Execute MedDRA coding and WHO-DD classification with high accuracy
• Prepare Periodic Safety Update Reports for Pregnancy case reconciliations & data discrepancy in close collaboration with Safety Operations Specialists
• Allocate Tasks manually & through automated BOT
• Support audit and inspection readiness, ensuring adherence to GVP and SOP standards
• Act as Subject Matter Expert (SME) for Pregnancy and Medical Device case handling
• Mentor Global teams and contribute to Training and Knowledge Transfer initiatives
• POC for Global Patient Safety to NextGen Safety (Argus – Veeva Safety) Transition
• Contribute to case quality improvement and deviation reduction initiatives
• Benchmarking foundation of LEAP (Learning from your Peers) initiative to aid Peer learning, Competency development & boost People Engagement
• Strongly collaborate with Safety-Surveillance Medical Advisors in reconciliation of Investigational Results of Technical Complaints, IMDRF codes in accordance with EU Medical Device Regulation

Drug Safety Associate I - Novo Nordisk

(2022-08 - 2023-08)

• Managed high-volume case processing workflows ensuring accuracy and compliance
• Proficient in Spontaneous case detected in CT, Haemophilia, Partner (PumpCart cases) from Roche & Ypsomed, IQVIA-EVERSANA cases in compliance with Safety Data Exchange Agreement
• Executed content transfers within and between ARGUS and CCGloW (Customer Complaints Handling), ensuring accurate migration of documents maintaining data integrity and continuity: Acted as CCGloW Super-User
• Dynamically collaborated with Safety Operations Submission (SO-PV Tech) team to fix blockers on manual intervention on regulatory reports transmission: Developed tool-book with checklists to minimize submission failures
• Performed coding, validation, and reportability assessments
• Supported regulatory audits and internal quality checks
• Pioneered multiple Process simplification initiatives by challenging status quo, raised Document Change Requests in SOPs, served as numerous Process Owner
• Managed Query Management Dashboard and Affiliate mailbox
• Documented feedbacks of Case Entry Quality via forms to maintain the quality data for each case and sent feedback to associates at case level
• Collaborated with cross-functional stakeholders and other external Novo Nordisk Vendors to resolve case discrepancies

Drug Safety Associate (Trainee) - CareerNet Technologies Pvt. Ltd. (Deployed at Novo Nordisk)

(2021-08 - 2022-08)

• Processed ICSRs in Argus safety database ensuring timely submission
• Performed narrative writing, Date of Birth Review, follow-ups, served as SPOC for routine Risk Management Plan Checks and Non-Serious Line Listing Review and handled case validation, clean-up, case closure activities
• Handled E2B R2/R3 cases received from Regulatory Authorities with strong vigilance on Word Wide Unique Case Identifiers, E2b Authority number & back transferred cases with batch numbers and unusual failure of efficacy to CCGloW to ensure compliance with worldwide safety data regulation and company policies
• Supported SOP review, Manual QC, workflow optimization, and KPI (Key Performance Indicator) tracking
• Participated in Root Cause Analysis (RCA) for Time Limit Exceeding & Amendment Reports, CAPA management, anchored multiple case management meet-ups and Townhall discussions

Pharmacist In-Charge - Ayushi New Life Medical, Hooghly

(2020-10 - 2021-08)

• Managed dispensing, inventory, and patient counseling
• Ensured compliance with pharmacy and regulatory standards

Pharmacist In-Charge - Kalimata Medical Hall, Howrah

(2018-01 - 2019-03)

• Delivered patient-centric pharmaceutical care and medication management
• Ensured compliance with pharmacy regulations

Master of Pharmacy - Pharmacology - Guru Nanak Institute of Pharmaceutical Science and Technology (2021)

Bachelor of Pharmacy - Guru Nanak Institute of Pharmaceutical Science and Technology (2019)

Diploma in Pharmacy (2016)