D Pharma Jobs at Novartis | PV Compliance and Quality Manager
Pharma jobs. Applications are invited for the post of PV Compliance and Quality Manager @ Novartis.Career @ Novartis. Pharma job opportunity at Novartis. PV Compliance and Quality Manager post vacancy. Interested candidates may apply online. Check out all the details on the same below:
Job ID 268617BR
Position Title PV Compliance and Quality Manager- Pharma jobs
- Minimum 4 to 7 years of experience in the pharmaceutical industry, particularly pharmacovigilance
- Experience in project management and demonstrated abil-ity to lead working groups in a matrix environment
- Ability to deal and interact with a wide variety of people at all levels.
- Strong organizational skills
- Strong negotiation, presentation and communication skills, and ability to operate effectively in an international envi-ronment and across functions
- Strong analytical skills
- Quality focus
- Ability to mentor and coach
- Develop and implement quality and compliance metrics for new safety case management and aggregate reporting processes, working with the process/metrics owners, Quality Assurance (QA) and other global line functions as appropriate. Lead projects to optimize methodologies and processes used to monitor safety cases and aggregate reports quality as well as internal and regulatory compliance:
- Develop and maintain tools in collaboration with Innovation, Tech & Systems and other Global Line Functions to assist in the monitoring of quality and compliance, introducing automation where possible.
- Maintain procedural documents including manuals
- Develop and implement training material and communications Assess the impact of any changes to worldwide regulations and/or Novartis group processes on existing metrics and update as required in order to ensure continued suitability. Review feedback from Health Authorities or other external parties and prepare responses and integrate the feedback into Novartis group standards as appropriate. Manage assigned monitoring activities/metrics production:
- Lead investigations in to any deficiencies identified, develop and implement corrective and preventative actions (CAPAs) and measuring the effectiveness of these. Act as a subject matter expert during audits and inspections (e.g. FDA and EMA), lead the preparation of responses to findings and the development and implementation of CAPAs.
- Collaborate with other Global Line Functions across Novartis Divisions, including Patient Safety Alliance, EU Qualified Person for Pharmacovigilance (QPPV), medical affairs and marketing to en-sure implementation of CAPAs and fulfillment of the safety requirements.
- Escalation to CMO&PS leadership and other global line functions as appropriate and/or External Service Providers (ESPs) of compliance/quality issues. Represent CMO&PS externally as a subject matter expert on compliance and quality.
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