Novartis Released Job Openings On 03/08/2022.Novartis is a global healthcare company based in Switzerland that provides solutions to address the evolving needs of patients worldwide.Eligibility for the AD Development Data Integrity as follows.
Novartis Recruiting Pharmacy,Science,Medicine Graduates with 03-10 years of experience for AD Development Data Integrity Position.Complete Details for the AD Development Data Integrity as follows.
Important Details :
- Location : Hyderabad
- No of Vacancies:Not Disclosed by Recruiter
- Details of Salary: Not Disclosed by Recruiter
- Opening date for online Application: 03/08/2022
- Mode of application :Online
- How To Apply: At the End of the Article We Have Provided Source Link,Please Go through that and Follow Necessary Steps
Job Description/Skills Required
- The Associate Director Development Data Integrity provides key operational and strategic oversight supporting continuous improvements of Data Integrity-relevant structures, processes and systems for Global Drug Development (GDD) including all Good Clinical Practice (GCP) and Pharmacovigilance (PV) relevant sub-functions. It supports the GDQ/GDD implementation of behavioral culture change, business process and system improvements to enhance Data Integrity (DI) controls within GDQ/GDD function.
- Collaborates with Business partners, Global Development Quality (GDQ) groups and Country QA to ensure International Council Harmonization (ICH)/GCP requirements as the foundation for Clinical/PV DI are fully met via the implementation of a risk-based implementation and execution of the GCP/PV processes.
- In collaboration with GDD and other GDQ organizations, implements actionable and functionable DI risk and issue trending to identify DI hotspots related to the end-to-end Clinical Trial execution process. Evaluation of DI relevant quality issues and escalations. Providing functional Quality analysis and robust investigations of DI relevant escalations, support root cause analysis and corrective actions to mitigate DI issues.
- Identify ways to continuously improve DI risk and issue management, quality and compliance improvements with current regulations & company policies/procedures through partnership with Global Drug Development (GDD) and Global Development Quality (GDQ) groups.
- Provide input to the continuous improvement of quality and compliance management-relevant computerized systems, including the categorization and indexing of quality issues, audit and inspection findings and escalations.
- Effective implementation of a DI training and awareness campaign, focusing on the end-to-end clinical trial process and current regulatory DI requirements. The design and implementation of GCP/PV improvement activities resulting in improved clinical trial DI.
- Drive a culture of proactive, risk-based behavior focused on clinical trial data integrity, resulting in trustworthy clinical trials ready for sponsor-monitoring HA inspections. Provides functional expertise related to the quality, risks and compliance of DI in vendor-supported clinical trials operations.
- Alignment on the identification of continuous improvement areas for GCP/PV DI quality and compliance issues, meeting latest external regulatory expectations on Clinical Trial Risk Management mandated by ICH E6 R2 Chapter 5.