Nirmal Nanu

• Served as Argus safety deputy system owner and administrator. • Managed 40+ clinical trial/post marketed safety projects across geographically dispersed team. • Worked with various biopharmaceutical clients and implemented Argus safety database for their clinical/post marketed safety projects (drugs, biologics, medical devices). • Configured and maintained the Argus safety database for over 50 safety projects (initial configuration, E2B profiles setup, country specific reporting rules setup etc.)

• Managing various clinical trial/post marketed safety projects • Oracle argus safety database configurations, upgrades, maintenance, UAT development, setup of reporting rules, workflows, E2B profiles. • Work with QA and prepare the necessary documents for computer systems validations, which includes system change controls, customization request forms, validation plan, URS, UAT plan, OQ/PQ/UAT, UAT report, validation summary report, traceability matrix etc. • Managing over 18 pharmacovigilance team members

• Subject matter expert in safety database systems (e.g. Argus, Aris-G). • Mailbox handling and triaging of incoming cases to prioritize for daily workflow management. • Mentoring and training for new hires. • SAE reconciliation between safety and clinical databases. • Conduct training sessions for the team members on various safety topics. • Schedule daily/weekly meetings with sponsor/client to provide accurate status of safety projects. • Participate in PV audits and inspections

• Assist in safety management activities for five prime sponsored clinical trials. • Case data entry (including narrative or auto-narrative), manual coding, label and approval. • Assist with periodic reconciliation of SAEs between the drug safety and clinical trial databases for ongoing clinical studies. • Subject matter expert in case processing conventions and guidelines, client's procedures and international drug safety regulations. • Conducting training sessions for various safety topics

• Safety mailbox handling. • Triage of incoming cases to prioritize for daily workflow management. • End to end case processing in safety database systems (e.g. Argus, ARIS-g). • Data entry, medical/drug coding using MedDRA and WHO-DD, narrative writing. • Quality review of ICSRs

Pharmacotherapy, Clinical Research, Pharmacology