Assistant Manager Case Processing
- Noida, Uttar Pradesh
- Permanent
- Full-time
- Performing triage and review for initial validity assessment of cases including spontaneous, health authority, Clinical Trial and literature cases.
- Responsible for quality management, workload management, compliance management and document management for the assigned PV projects
- Evaluation of the need for expedited reporting to Health Authorities / partners of a client concerned, including reporting timelines
- Preparation of standard reporting forms (e.g., 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
- Acts as line manager of assigned staff
- Manages project coordination and resource allocation within the projects
- Train and mentor PV department staff, as needed
- Ensures monthly invoices are generated and shared for all PV clients on regular/monthly basis
- Responsible for recruitment of new staff in PV Department
- Ensures all departmental CVs, job descriptions and training records are complete and up to date and as per SOPs
- Is involved in goal setting and annual appraisals of staff
- Participate in the goal-setting process and conduct annual appraisals for staff, providing constructive feedback and support to foster individual development and align team objectives with organizational goals.
- Ensures training compliance by PV staff at all times
- Represents PV department during for-cause/maintenance client audits or regulatory authority inspections
- Ensure compliance with internal standards and external (national and international) regulations
- To write/ review QA documents such as SDEA’s, Working Instructions, SOPs, Working Procedures, templates, project metafiles etc. for PharmaLex Pharmacovigilance projects
- To organize and perform training of the above-mentioned documents
- Case processing including data entry and QC
- Case completion / documentation.
- 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.
- Performing triage and review for initial validity assessment of cases including spontaneous, health authority, Clinical Trial and literature cases.
- Responsible for quality management, workload management, compliance management and document management for the assigned PV projects
- Evaluation of the need for expedited reporting to Health Authorities / partners of a client concerned, including reporting timelines
- Preparation of standard reporting forms (e.g., 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
- Acts as line manager of assigned staff
- Manages project coordination and resource allocation within the projects
- Train and mentor PV department staff, as needed
- Ensures monthly invoices are generated and shared for all PV clients on regular/monthly basis
- Responsible for recruitment of new staff in PV Department
- Ensures all departmental CVs, job descriptions and training records are complete and up to date and as per SOPs