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| Job Location | Hyderabad |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | Medical / Healthcare |
| Functional Area | General / Other Software |
| EmploymentType | Full-time |
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 ESPs 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 quality 4.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
Minimum requirements
Graduate/Post Graduate/Doctorate degree in Life Sciences/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
,Keyskills :
dataentry drugsafety lifesciences datamanagement caseprocessing safetymanagement communicationskills qc esp testing medical metrics database coaching clinical marketing authoring mentoring oversight tatementsofworksow