Assistant Manager Case Processing

Job Description 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.