Novartis
Location
Secunderabad | India
Job description
Monitor all case processing related activities to facilitate oversight on ESP s quality and compliance of deliverables. Provide coaching and mentoring to all case processors including ESPs
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 quality
Lead/support the process changes according to internal and externals drivers, including development and monitoring of process related metrics
Support in audits/inspection as Subject Matter Expert, and develop and implement Corrective and preventative Actions (CAPA) to address safety findings
Develop, contribute and maintain guidance documents including providing inputs to Vigilance Agreement (VA) and other such safety management plans
Support in-collaboration with other functions within PS&PV to facilitate process improvements; Collaborate with Data Management team to enable reconciliation for 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 databased, authoring or contributing to Product Specific Guidelines for assigned products. Lead the testing activities for case processing related safety systems/IT applications. Train and mentor new PS&PV associates
Work with Novartis country safety departments, License partners and medical function to ensure that reports are accurately collected, evaluated and data based. Lead PS&PV Operational Projects or database validation activities as required
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Role Requirements
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 tags
Salary
