Manage project-specific activities which may include preparation or review of safety management plan, data management plan, case report forms (as required), preparing safety databases such as Veeva Vault Safety, ArisG, Argus and cubeSAFETY, prepare configuration documents for each project; preparing slides for project kick off meetings, provide study specific safety reporting trainings to investigators/ study team and end to end PV project management.
Case processing activities and drafting safety narratives, monitoring of safety mailbox, filing study documents in trial master file (TMF).
Manage site and regulatory submissions for both expedited and periodic reports (line listings and DSUR)
Act as key contact or point of expertise for team members and external contacts for designated projects/ processes
Participate in safety reconciliation activities, as requested by client.
Liaison with medical monitors/ Pharmacovigilance physicians, clients, and study teams as appropriate to clarify information required.
Participation in inspection/ audit related activities; Assistance in preparation or implementation of corrective/ preventative actions relating to case processing.
Timely submission of reports to regulatory agencies in accordance with applicable regulations and tracking the details of submissions for compliance.
Any other responsibilities as assigned by the line manager.
Responsibilities
Manage project-specific activities which may include preparation or review of safety management plan, data management plan, case report forms (as required), preparing safety databases such as Veeva Vault Safety, ArisG, Argus and cubeSAFETY, prepare configuration documents for each project; preparing slides for project kick off meetings, provide study specific safety reporting trainings to investigators/ study team and end to end PV project management.
Case processing activities and drafting safety narratives, monitoring of safety mailbox, filing study documents in trial master file (TMF).
Manage site and regulatory submissions for both expedited and periodic reports (line listings and DSUR)
Act as key contact or point of expertise for team members and external contacts for designated projects/ processes
Participate in safety reconciliation activities, as requested by client.
Liaison with medical monitors/ Pharmacovigilance physicians, clients, and study teams as appropriate to clarify information required.
Participation in inspection/ audit related activities; Assistance in preparation or implementation of corrective/ preventative actions relating to case processing.
Timely submission of reports to regulatory agencies in accordance with applicable regulations and tracking the details of submissions for compliance.
Any other responsibilities as assigned by the line manager.
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