Senior Executive - PSUR & PBRER

Job Description

The role requires the individual to support Management of Periodic reporting by collation and review of Periodic safety update reports and support Co-ordination activities for Emerging Safety Issues (ESIs)/ Foreign Action Notification (FRNs) . Details of the responsibilities: 1. Authoring or Quality Review of PSURs (Periodic Safety Update Reports) / PBRERs (Periodic Benefit-Risk Evaluation Report) Extraction/Review of Line listings from Company Safety Database Literature Review for PSUR/PBRER Collation/Review of PSUR/PBRER template Collation/Review of MAS (Marketing Authorization Status) Estimation/Review of Sales and Patient Exposure Preparation/Review of Appendices to the PSURs/PBRERs Perform archival activity of Periodic reports 2. Foreign Safety Notification (FRN)/ Emerging Safety Issue (ESI)/ Significant Safety Issue (SSI) Coordinator activities Screening emails received from the stakeholders to identify the FRNs/ ESI/ SSIs Supporting dissemination and tracking of the FRNs/ ESI/ SSIs to all RPPs/designee Maintaining the tracker for foreign notifications Perform daily reconciliation of FRNs/ ESI/ SSIs as per SOP035118 Support the activity of regulatory websites screening as a back-up on an as required basis for foreign notifications3. 3. PSUR Regional Administration / Co-administration / Administration Responsibilities Preparation and review of PSUR calendars Monitoring PSUR regulatory submission compliance Ensure SDEA compliance to PSURs/PBRERs Evaluation & implementation of PSUR guidelines/ regulations Monitoring of Archival Status, Co-ordination with the regional team for PSUR related issues, Identification of PI Revisions for Safety Updates & Addressing regional/Agency Queries/RFIs Initiate Deviation, Collation/Review of Monthly Compliance Reports and CAPA Management