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.
