Manojkumar Poonia

Case Management (End-to-end ICSRs operations) PV Training Audit and Inspection readiness CAPA creation, review and approval QPPV office activities including PSMF Maintenance KPI negotiation, creation, and oversight SDEA and PVA negotiation and management Create and Update quality documents SOPs/WIs/Process Manuals/SDEAs/, etc. Implementation of PV updates Interaction with internal and external stakeholders Project management in PV Automation projects Actively participated in the recruitment process

Case Management (End-to-end ICSRs operations) PV Training Audit and Inspection readiness CAPA creation, review and approval QPPV office activities including PSMF Maintenance SLA and KPI negotiation Vendor management SDEA and PVA management Quality documents SOPs/WIs/Process Manuals/SDEAs/, etc. Implementation of PV updates into PV system PSURs SDEA and PVA Team Trainer and SME Project management Signal Management Medical information Actively participated in the recruitment process

1. Managed daily operations in conjunction with Associate Vice President Pharmacovigilance-EU for assigned clients for ICSRs, and other tasks relevant to the Pharmacovigilance Department. 2. Managed a team of 16 members. 3. Developed career plans for direct reportees 4. Managed end to end Pharmacovigilance operations for two Global Pharmaceuticals organizations for EEA region. 5. Prepare and participate in audits and inspections for the assigned clients from ICSRs operations perspectives. and more.

1. Management of safety data exchange process with client and/or its business partners. 2. Update SOPs/WIs/Process Manuals/SDEAs/, etc. 3. Identification and implementation of Pharmacovigilance updates to client’s PV system. 4. Coordination among Signal management, PSUR, RMP, XEVMPD, and regulatory departments from ICSRs operations perspectives. 5. Comprehensive knowledge and understanding of ARISg and ARGUS safety database, 6. EMBASE literature monitoring and review for ICSRs detection. and more.

Processing and QC of all types of ICSRs.

Processing of ICSRs, Spontaneous and Solicited ICSRs.

Worked as a CRA trainee in clinical pharmacokinetics and biopharmaceutics department (BA/BE Studies), Wockhardt Ltd., Mumbai for around 9 months.