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Job Location | Chandigarh |
Education | Not Mentioned |
Salary | Not Disclosed |
Industry | Pharma / Biotech |
Functional Area | Journalism / Writing |
EmploymentType | Full-time |
Preparing end to end PSURs (including ad-hoc requests) in accordance with client requirements/conventions and Standard Operating Procedures (SOPs) Liaising with the relevant stakeholders regarding discrepancies, and for obtaining incomplete/missing information (where required), in order to resolve and clarify issues and to facilitate processing of the reports Maintaining excellent knowledge of the safety profile of the assigned products, client s procedures and international drug safety regulations Maintaining an awareness of global regulatory requirements and reporting obligations and organizing workload to ensure compliance with timelines communicated by the client Performing self QC of reports Ensuring MedRDA coding in accordance with MedRDA Term Selection: points to consider where applicableQualificationsScience/Medicine degree: The minimum qualification required would be a university degree in life Sciences (PhD., Pharmacy, microbiology, Biochemistry, Biotechnology, Biophysics etc.)A degree in Medicine/Dentistry/Physiotherapy/Experimental Medicine/Nursing, which involves patient exposure in hospital-based environment, would be an advantage,
Keyskills :
clinical trialssafetyprotocolsresearchliteraturestandard operating proceduresdrug safetymusic makinglife sciencescompatibility testingregulatory requirements