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Job as Policies, Processes & Verification Associate in Novartis

 

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A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.

Post: Policies, Processes & Verification Associate

Job Description:
Supports the management of global DS&E inspection readiness, verification and implementation of corrective actions by managing and monitoring the Pharmacovigilance systems, improve and implement new processes
1. Support entry of deviations, corrective actions and preventative actions (CAPA) compilation for global DS&E & local DS&E in the AQWA system.
2. Support the maintenance of accurate, efficient and uniform processes and up-dated procedural documents within DS&E that assure worldwide regulatory reporting requirements are met for marketed and development compounds.
3. Assist in the tracking of all procedural documents for full oversight and inclusion in PSMF.
4. Support the generation of the periodic reports on quality metrics for global processes within DS&E. Support development of quality metric tools and enhancements.
5. Support inspection/audit readiness, through quality and consistency measures for single case processing
6. Contribute to the worldwide ICSRs compliance oversight with management and collation of incoming data from CPOs, or on behalf of CPOs, and investigation of late submissions for the delay point.
7. Interface with CPOs and central functions to obtain compliance information
8. Support the management of the ICSR regulatory rules database.
9. Play an active role in alerting Head PPV to potential compliance issues
10. Inspection preparation and outcome measures
11. Efficiency of implementation of new procedures and processes
12. Quality & ICSR compliance metric tracking
13. Timely AQWA management

Minimum requirements:
Life science or pharmacy degree. Fluency in English. Knowledge of other language desirable but not essential

• New graduates with no or internship experience to 1-2 years of industry experience
• Understanding of the drug development process of pharmaceutical medicine.
• Basic knowledge of functional requirements of drug safety/ pharmacovigilance.
• Experience and ability to work in matrix cross-functional environments.
• Excellent communication skills with good written and oral command of English

Additional Information:
Job ID: 186191BR
Location:
Hyderabad
Division: Pharma
Business Unit: Global Develop NPH
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: R&D

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