Assistant Manager Case Processing

Job Details

• 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
• 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
• 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.

Skills Required

Regulatory Compliance