Aggregate Reports and Risk Management Analyst

Aggregate Reports & Risk Management Analyst

Job Description Summary

Support in managing the operations of aggregate reports & risk management team’s deliverables for Development organizational unit product portfolio encompassing preparation of reports, scheduling, quality review, compliance, audit readiness, tracking and dispatch of reports. Support to the management of projects run by PS&PV as required.

Job Description

1.     Support in preparation of assigned aggregate & risk management reports.

2.     Retrieve data from global databases as per Novartis SOPs for report preparation.

3.     Support QC of assigned aggregate reports to ensure the information presented is complete, consistent and compliant to sources, as well as regulatory and Novartis templates, standards, and requirements. 

4.     Support to the management of projects run by PS&PV as required.

5.     Support in managing all AR&RM deliverables of scheduling and related activities required for business.

6.     Support in coordination with licensing partners to meet joint accountabilities.

7.     Support in preparation, follow-up and closure of RCA/CAPA & Quality Incidents.

8.     Support Inspection and audit readiness (eg. archival of ongoing activities)

9.     Collaborate in all automation initiatives.

10.  Coordinate in collection, distribution and archiving of relevant documentation (e.g. Certificates, Cover page signatures).

11.  Handling inbound & outbound emails passing through AR&RM mailboxes

12.  Co-ordinate, publish and/or dispatch of assigned reports.

13.  Act as Super Users of tools and systems in support of preparation and finalization of AR&RM deliverables.

14.  Collection of data and preparation of metrics for Presentation of Metrics in respective boards or forums. Metrics & Compliance Tracking of various AR&RM indicators.

15.  Complete HA AR&RM Tracker for assigned products/deliverables timely to ensure inclusion of the comments in the respective report.

16.  Maintenance, and guidance on Tracking tools, and Sharepoint, and Shared drives

17.  Support projects related to operational excellence and implementation of Artificial Intelligence solutions and other advanced tools to simplify and facilitate core activities of the AR&RM team (including testing of safety systems/IT application)

18.  Support the preparation of AR&RM compliance quarterly reports for dissemination to senior management and EU QPPV Office.

 

19.  Preparation and maintenance of reports on AR&RM activities which contribute to regulatory documents, e.g. PV master file, and ongoing tracking of PS&PV quality metrics.

20.  Train/onboard the new hires colleagues in assigned AR&RM processes and topics.

21.  Adhere to good documentation practices to ensure audit/inspection readiness.

22.  Support general administrative tasks required to enable AR&RM operations. 

Key Performance Indicators :

1.     Timely and accurate tracking, reporting and documentation.

2.     Good documentation practices

3.     Good practices in project management

4.     Audit and inspection readiness.

5.     Adequate support to required activities for assigned deliverables. 

Skills Desired

Databases, Employee Training, Filing Documents, Pharmacovigilance, Reporting, Safety Science

Experience Level

Senior Level