Specialist, Pharmacovigilance, Epidemiology & Risk Management
ConfidentialNoida6 days ago
Job descriptionAuthority, Clinical Trial and literature cases. Data entry into PV database Initial ICSR assessment, if applicable Evaluation of the need for expedited reporting to Health Authorities / partners of a client concerned, including reporting timelines Preparation of standard reporting forms (eg, CIOMS I / MedWatch Forms and XML files) Preparation and sending of follow up requests Submission of ICSRs to Health Authorities and partners of a client Case completion / documentation Conduct quality checks of Individual Case Safety Reports (ICSRs) and ensure quality assurance in accordance with project requirements, maintaining compliance with industry standards and best practices to enhance the integrity and reliability of safety data. The ICSR search / retrieval process from the EVWEB database and company / non-company assessment for cases. Allocation and cases workload management Providing training of the system to the respective team members. Actively mentor and support new joiners by providing guidance on company processes, facilitating their integration into the team, and fostering a collaborative learning environment to enhance their professional development. Responsibilities will be assigned by the supervisor in accordance with process requirements
Skills Required
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Risk Management • Noida