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| Job Location | Pune |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | Medical / Healthcare |
| Functional Area | Allied Health Services |
| EmploymentType | Full-time |
JOB SUMMARYThe position is responsible for performing medical review of Individual Case Safety Reports (ICSRs),conducting medical assessement of all safety related data and ensuring medical accuracy of the ICSR narrative, coding and appropriate medical interpretation of all cases.JOB RESPONSIBILITIESPerforms medical review of adverse events reported for investigational and marketed products.Maintains familiarity with MedDRA, WHO-DRL, and safety databases such as ARGUS.Works closely with Safety and Pharmacovigilance (SPVG) colleagues to ensure appropriate medical interpretation and consistency are applied to adverse event case assessment.Ensures regulatory and SOP compliance with respect to evaluation, reporting and surveillance of clinical and post-marketing safety information.Identifies, communicates and effectively manages potential safety issues.Interacts with client s safety/medical personnel as appropriate.Stays abreast of clinical and drug development information relevant to contracted programs.Provides medical review and interpretation for aggregate safety reports (e.g. annual safety reports,PSURs, PADERs).Maintains medical and pharmacovigilance expertise through appropriate internal or external continued medical education.Assists as a mentor and trainer for other internal safety staff including case processing staff.Responsible for performing activities that are in compliance with applicable Corporate and D Departmental Policies, Standard Operating Procedures, Work Instructions and any project specific Operating Guidelines.Performing other duties as assigned by management., *Qualifications required :
Keyskills :
standardoperatingprocedures musicmaking medicalreview adverseevents caseprocessing drugdevelopment workinstructions professionalliability pv sop psurs meddra clinical reporting hospitals databases edical