Pharma Senior Safety Expert Job Opening @ Novartis
Pharma Senior Safety Expert M.Pharma expert. Pharmaceutical Jobs. Applications are invited for the post of expert@ Novartis.Career @ Novartis. Pharma job opportunity at Novartis.vacancy at Novartis. Interested candidates may apply online. Check out all the details on Rasayanika.com
Job ID 280210BR
Position Title Senior Safety Case Expert
Minimum requirements
• Graduate/Post Graduate Pharmacy/Medical Sciences or equivalent degree Fluency in English. Knowledge of other languages desirable.
• 3 to 5 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. Monitor all case processing related activities to facilitate oversight on ESP’s quality and compliance of deliverables
2. Provide coaching and mentoring to all case processors including ESP’s
3. Evaluation and QC of Serious Adverse Event / Post Marketing Adverse Event to ensure accurate and consistent data entry
and processing from source documents, with emphasis on accuracy, timeliness and quality4. Lead/support the process changes according to internal and externals drivers, including development and monitoring of process related metrics
5. Support in audits/inspection as Subject Matter Expert, and develop and implement Corrective and preventative Actions (CAPA) to address safety findings
6. Develop, contribute and maintain guidance documents including providing inputs to PVA and other such safety management plans
7. Support in-collaboration with other functions within CMO&PS to facilitate process improvements
8. Collaborate with Data Management team to enable reconciliation for locking of Clinical database
9. Alert the Medical Safety Physicians of potential safety issues and assist the Medical Safety Physicians in monitoring the safety profile of products.
10. 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. 11. Lead the testing activities for case processing related safety systems/IT applications
12. Train and mentor new CMO&PS associates
13. Work with Novartis country safety departments, License partners and medical function to ensure that reports are accurately collected, evaluated and data-based.
14. Lead CMO&PS Operational Projects or database validation activities as required
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