Nirmal Nanu
Bis 2022, Manager, Drug Safety Operations, Clinipace
London, Vereinigtes Königreich
Über mich
Manager, drug safety operations (Argus safety system administrator) with 8+ years of experience in pharmaceutical drug safety/pharmacovigilance operations. Worked at multiple clinical research organizations (CRO) and has wide exposure and broad knowledge of the industry. A self-motivated worker with experience in clinical trial studies and post-marketing safety programs in both small and large company environments.
Werdegang
Berufserfahrung von Nirmal Nanu
11 Monate, Sep. 2021 - Juli 2022
Manager, Argus Administration
Clinipace
• 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.)
5 Jahre und 1 Monat, Juli 2017 - Juli 2022
Manager, Drug Safety Operations
Clinipace
• 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
10 Monate, Juni 2013 - März 2014
Drug Safety Associate
MMSH Clinical Research
• 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
Ausbildung von Nirmal Nanu
Bis heute 2 Jahre und 10 Monate, seit Sep. 2021
Health Data Science
Swansea University
2 Jahre, Aug. 2010 - Juli 2012
Pharmacy
National Institute of Pharmaceutical Education & Research
2 Jahre und 1 Monat, Juli 2010 - Juli 2012
Pharmacy
National Institute of Pharmaceutical Education and Research
Pharmacotherapy, Clinical Research, Pharmacology
4 Jahre und 11 Monate, Sep. 2005 - Juli 2010
Pharmacy
University of Calicut
Sprachen
Deutsch
Grundlagen
Englisch
Fließend
Malayalam
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