PSUR / PADER / Signal Draft

1.PSUR & RMP Authoring

Key Responsibilities:

• Authoring and Reviewing PSURs and RMPs

Prepare and review Periodic Safety Update Reports (PSURs/PBRERs) and Risk Management Plans (RMPs) for submission to health authorities.

Ensure the accuracy, completeness, and regulatory compliance of all PSURs and RMPs.

• Literature Search and Validation

Perform literature searches to gather relevant data for PSUR and RMP preparation.

Validate the information obtained from literature searches to ensure accuracy.

• Data Management

Extract and validate data from various sources, including Reference Safety Information (RSI), sales data, previous reports, and Risk Management Plans (RMP).

Generate Line Listings (LL) from the safety database for inclusion in PSURs.

• Process Management

Manage and reconcile relevant process trackers to ensure all activities are documented and on schedule.

Provide reliable support for high-priority ad-hoc activities related to PSUR preparation.

• Client Interaction

Communicate with client personnel to resolve issues related to PSURs, ensuring adherence to client policies.

Ensure that PSUR deliverables comply with regulatory requirements and are submitted within agreed timelines.

• Subject Matter Expertise and Training

Serve as a subject matter expert (SME) for PSUR preparation and review.

Provide training and mentoring to team members on PSUR-related processes and regulatory requirements.

2.PADER report Authoring

Key Responsibilities:

1. Draft PADER aggregate reports as per the aggregate reporting schedule.

2. Prepare line listings and tabulations for inclusion in the PADER report.

3. Develop and maintain the PADER report calendar and schedule.

4. Coordinate and resolve queries with cross-functional teams before finalizing line listings, addressing any issues identified in draft cases.

5. Communicate with cross-functional teams to obtain required inputs and resolve queries efficiently.

6. Archive all PADER-related information in the designated shared drive.

7. Submit PADER documents and reports within specified timelines, ensuring compliance with internal and regulatory submission requirements.

8. Prepare and review SOPs and work instructions in alignment with ICH-GCP, GVP modules, and FDA guidelines.

9. Provide training to junior associates on PADER report preparation and processes.

10. Support client audits and regulatory authority inspections as needed.

3. Signal Management

Key Responsibilities:

• Safety Signal Detection and Triage:
• Perform safety signal detection and triage activities for a challenging product portfolio.
• Identify new safety signals based on review and comprehensive medical evaluation of technical hits in post-marketing spontaneous reporting databases, analyzing single case reports as well as aggregate data available.
• Expert Evaluation:
• Provide expert evaluation of results of post-marketing signal detection activities at cross-functional team meetings, including Safety Review Meetings and Joint Safety Committees as appropriate.
• Collaboration:
• Collaborate productively with the safety leads for the respective products.
• Serve as a core member of the cross-functional Signal Management Team, providing expert input for post-marketing signal detection activities using internal and external spontaneous reporting databases.
• Database Searches and Analysis:
• Perform database searches in external Health Authority databases (FAERS, Vigibase, iDAP, DAEN), analyzing and reporting the results.
• Perform QC checks of Health Authority database searches done by colleagues.
• EudraVigilance Management:
• Manage EudraVigilance database requests, including monitoring EudraVigilance for assigned products.
• Provide support in training and mentoring junior Safety Signal Colleagues.
• Development of Guidance Documents:
• Drive the development and update of Business Guidance documents and SOPs.
• Contribute to the development of new approaches for automated signal detection in internal/external databases