Performing triage and review for initial validity assessment of cases including spontaneous, health authority, 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.
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
Regulatory Reporting, Quality Assurance
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Senior Specialist • Noida
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