Job Description :
- Subject Matter Expert
- Contribute to DS&E projects
- Assess seriousness, causality and labeling of serious adverse events and quality check ICSRs to ensure accurate and consistent Argus data entry from source documents.
- Author/co-author, along with Global Medical Safety Physicians, regulatory periodic safety re- ports (Periodic Safety Update Reports, US Periodic Reports) for Novartis mature portfolio: collecting, organizing, analyzing and presenting the data by means of DS&E templates and procedures.
- Lead/co-lead cross functional expert teams to fulfill Periodic Safety Report accountabilities (DRA, Clinical, Marketing).
- Review global marketing programs and establish process for AEs collection with global marketing teams.
- Review Risk Management Plans in coordination with Global Medical Safety groups and assess the operational feasibility and implications of Pharmacovigilance commitments.
- Collaborate with Electronic Data Management team to reconcile Serious Adverse Events be- tween the Clinical and Safety databases to meet joint accountabilities and enable locking of Clinical database.
- Alert the Medical Safety Physicians of potential safety issues and assist the Medical Safety Physicians in monitoring the safety profile of products.
- Member of Safety Profiling Teams to ensure that case reports are accurately evaluated and database, authoring or contributing to Product Specific Guidelines for assigned products.
- Contribute to the preparation of Standard Operating Procedures and Argus processing conventions (MAP).
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