Title: Senior Executive - PSUR & PBRER

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