Jonaid Ali
6+ Years in ICSR Case Processing and Case Intake | Argus/Arisg | GVP/GCP Compliance | Regulatory Reporting (EMA FDA MHRA) l Medical device, Drugs & Vaccine l Master in Pharmacology from JAMIA HAMDARD l Pharmacovigilance
- Role
- Business Process Lead at Tata Consultancy Services
- Location
- Pune District, MH, IN
- LinkedIn followers
- 500 followers
About Jonaid Ali
Intake and triage of solicited, spontaneous, literature, and clinical trial cases -…
Experience
Business Process Lead
Jan 2023 — Present · Pune, IN
Perform case intake and triage of adverse event reports received from multiple sources (spontaneous, solicited, literature, clinical trial, patient support programs). • Enter and process Individual Case Safety Reports (ICSRs) in global safety databases. • Conduct duplicate check, seriousness assessment, MedDRA coding, WHO-DD drug coding, and narrative writing. • Identify and handle special cases such as pregnancy, pediatric, fatal, and product quality complaints. • Ensure regulatory reporting compliance with global authorities (e.g, FDA, EMA, MHRA, Health Canada) within stipulated timelines (7-day, 15-day, 90-day). • Perform quality checks on processed cases to maintain accuracy and audit readiness. • Communicate with clients for follow-ups, clarifications, and reconciliation of safety data. • Adhere to project-specific SOPs, Amgen guidelines, and Good Pharmacovigilance Practices (GVP). • Participate in training, knowledge sharing, and continuous proce
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