Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post : Safety Case Expert
• 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
• Perform daily quality review (QR) for Individual Case Safety Reports (ICSR) to allow analysis of data entry/quality
• Support audits & inspections preparation activities and support implementation of Corrective and Preventive Actions
• Working in collaboration with the Country Organizations (COs) and ESPs for literature screening process Functional oversight on review of global marketing programs and establish process for AEs collection with global marketing teams
• 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.
• 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.
• 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.
• Graduate/Post Graduate/Doctorate degree in Life Sciences/Pharmacy/Medical Sciences or equivalent degree English
• 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
Experience : 2-4 years
Qualification : B.Pharm, M.Pharm, M.Sc
Location : Hyderabad
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Research & Development
ID : 289928BR
End Date : 25th March, 2020
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