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| Job Location | Hyderabad |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | NGO / Social Work |
| Functional Area | Sales / BD |
| EmploymentType | Full-time |
Your responsibilities include, but are not limited to:
Lead preparation of global periodic safety reports for newly launched products. Lead coordination with GLFs to ensure information received, analyzed and incorporated into ARs as per the regulatory requirements. Independent QC of ARs to ensure the information presented in AR is complete, consistent and compliant to regulatory and Novartis standards Support in creating strategy for data analyses and presentation in global periodic safety reports. Support in addressing the Health Authority (HA) comments adequately in PSURs. Support in the development of safety document templates and Standard Operating Procedures pertaining safety aggregate reports Contribute to global projects focusing on process quality improvement initiatives. Contribute as subject matter expert during Health Authorities inspections/audits and contribute in development, implementation of appropriate Corrective and Preventative Actions (CAPA). Train and mentor new CMOPS associates and associates from other line functions on medical safety writing periodic reporting matters. Support Head, Safety Report Writing/Head, Aggregate reports and assist with the recruitment of new staff.
Minimum requirements
Graduate/Post Graduate/Doctorate degree in Life Sciences/Pharmacy/Medical Sciences or equivalent degree Fluency in English. Knowledge of other languages desirable. 4 to 8 years experience in drug safety/ development or closely related areas of responsibility, with a minimum of 3 years experience in in safety/ medical/scientific/regulatory writing preferably, at least 2 years of experience in safety writing Sound expertise in data analysis and presentation Strong project management and communication skills. Ability to lead global and cross-functional work groups excellent understanding of drug development
,Keyskills :
processqualityimprovement standardoperatingprocedures dataanalysis reportwriting processquality drugdevelopment projectmanagement qualityimprovement qc ar ars sound writing strategy analysis reporting templates management regulatory edi