Novartis Pharma Expert Job Opening – Application Details
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Job Title: Safety Case Expert
Job Id: 285223BR
Minimum requirements
- Graduate/Post Graduate/Doctorate degree in Life Sciences/Pharmacy/Medical Sciences or equivalent degree Fluency in English. Knowledge of other languages desirable.
- 2 to 4 years of experience in drug safety / Development or closely related areas of responsibility Good professional verbal and nonverbal communication skills
- Self-motivation and proactive stance to work
- Sense of urgency and commitment for timely completion of activities
- Previous Pharmacovigilance data entry experience is desirable.
- Strong negotiation and ability to operate effectively in an global environment and across line functions
Job Description
Your responsibilities:
Your responsibilities include, but are not limited to:
1. Assess seriousness, causality and labeling of serious adverse events and quality check ICSRs to ensure accurate and consistent Argus data entry from source documents and product and event coding, narrative writing. Conduct follow-up for missing or other medical important information
2. Perform daily quality review (QR) for
Individual Case Safety Reports (ICSR) to allow analysis of data entry/quality3. Support process changes according to internal and externals drivers
4. Support audits & inspections preparation activities and support implementation of Corrective and Preventive Actions
5. Monitor metrics to ensure timely triggers for follow-up actions
6. Develop, contribute and maintain guidance documents
7. Working in collaboration with the Country Organizations (COs) and ESPs for literature screening process
8. Functional oversight on review of global marketing programs and establish process for AEs collection with global marketing teams
9. Collaborate with Trial Data Management team to reconcile Serious Adverse Events between the Clinical and Safety databases to meet joint accountabilities and enable locking of Clinical database.
10. Alert the Medical Safety Physicians of potential safety issues and assist the Medical Safety Physicians in monitoring the safety profile of products.
11. Member of Safety Profiling Teams to ensure that case reports are accurately evaluated and databased, authoring or contributing to Product Specific Guidelines for assigned products.
12. Support the development and testing of safety systems/IT applications and in the preparation of relevant manuals
13. Train and mentor new CMO&PS associates. Work with Novartis country safety departments, License partners, Clinical Safety Scientists and Pharmacovigilance Leaders to ensure that reports are accurately collected, evaluated and data based.
14. Assist with related administrative and procedural activities as required or requested.
15. Lead/Support CMO&PS Operational Projects or database validation activities as required. Provide functional inputs for PV agreements
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