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| Job Location | Hyderabad |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | Medical / Healthcare |
| Functional Area | General / Other Software |
| EmploymentType | Full-time |
Manager - Safety Case Processing Job Description 1. Lead and monitor the team performing and driving safety case processing and quality review activities to ensure compliance and quality including ESPs 2. Actively participate in audits / Inspections as Subject Matter Expert , and develop , monitor and implement Corrective and preventative Actions (CAPA) to address safety findings 3. Ensure workload monitoring and appropriate resources allocation 4. Liaising with across CMO&PS department to ensure that all tasks are performed according to business rules , guidelines and standard operating procedures 5. Interact with ESPs to review their performance and identify areas of development for capability building 6. Provide inputs to strategical decisions related to ESP and internal teams 7. Lead and manage changes within Case Management team 8. Represent case management in functional and operational forums 9. Support the training / interactions with other departments on case management related activities 10. Interact with internal stakeholders on project activities in specific therapeutic areas , compatibly with the timely processing / production of individual case reports and regulatory periodic reports. 11. Support the Medical Safety Physicians in monitoring the safety profile of a product. 12. Represent CMO&PS in the preparation of Standard Operating Procedures and Argus processing conventions 13. Deputize for Head Safety Case Processing in various forums and 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. 4 to 8 years experience in drug safety / development or closely related areas of responsibility , with a minimum of 3 years experience in safety Good professional verbal and nonverbal communication skills Sense of urgency and commitment for timely completion of activities Strong negotiation and ability to operate effectively in a global environment and across line functions Strong operational and project management skills. Ability to lead global and cross - functional work groups / projects Excellent understanding of drug development process , GCP and medical terminology Division Global Drug Development Business Unit CMO & PATIENT SAFETY GDD Country India Work Location Hyderabad , AP Company / Legal Entity Nov Hltcr Shared Services Ind Functional Area Research & Development Job Type Full Time Employment Type Regular,
Keyskills :
tandard operating proceduresdrug developmentbusiness rulestherapeutic areaspatient safetyglobal drug developmentmusic makingsafety casecase processingshared servicesproject manlife sciencesdrug safety