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 : Patient Safety Group Manager
Job Description
1. Implement and maintain the local Quality System in the areas of GCP and GPvP, in accordance with the Novartis Quality Manual and the CPO Quality Plan.
2. Conduct proactive in-process quality and compliance review through monitoring of adequate Key Quality Indicators (KQIs) and assure that gaps are addressed appro-priately in order to mitigate risk.
3. Conduct vendor assessment and/or qualification visits for locally outsourced clinical development, MA and Ppharmacovigilance (PV) activities, including vendors for Patient Oriented Programs (POP).
4. Support in the preparation, execution and follow-up of audits on clinical development activities. Together with the auditees, determine root causes for country-specific major and critical audit. Verify that appropriate corrective and preventive actions are implemented on all major and critical audit findings.
5. In cooperation with the local GMP QA Colleagues ensure analysis, assessment and res-olution (including CAPAs where indicated) of issues with common interfaces.
6. Participate in Clinical QA investigation activities, as appropriate.
7. Ensure CPO readiness for all GxP regulatory inspections.
8. Provide support prior to, during and after HA inspections of the CPO, investigational sites or external service providers, as applicable, together with the Novartis inspection lead. Ensures that responses to local Health Authorities have been submitted, commitments have been met and relevant CAPs have been completed/closed.
9. Ensure conduct of adequate training at the CPO for all GCP and GPvP activities by defining, planning and supporting training activities.
10. Ensure that the clinical and PV computerized systems are adequately identified during the High Level Risk Assessment for GxP relevance to enable their validation where required.
Candidate Profile
Degree in Life Sciences or related fields English fluent in speaking and writing Min. 3-4 years of experience in the pharmaceutical industry in a relevant field such as quality assurance, registration, clinical development or a directly related area.
Additional Information:
Experience: 3-4 years
Location: Mumbai
Education: Degree in Life Sciences
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: R&D
Job ID: 231611BR
End Date: 8th February, 2018
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