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 : PV Compliance & Quality Manager
Job Description
• Develop and implement quality and compliance metrics for new safety case management and aggregate reporting processes, working with the process/metrics owners, Quality Assurance and other line functions as appropriate. Lead projects to optimize processes used to monitor the quality of safety cases and aggregate reports as well as internal and regulatory compliance:
• Develop and maintain tools to assist in the monitoring of quality and compliance, intro-ducing 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 internal 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 in to Novartis standards as appropriate. Manage assigned monitoring activities / metrics production:
Lead investigations in to any defi-ciencies identified, develop and implement corrective and preventative actions (CAPAs) and measuring the effectiveness of these.
• Act as a subject matter expert on assigned quality and compliance monitoring activities and met-rics during audits and inspections.
• Act as a subject matter expert during audits and inspections, lead the preparation of responses to findings and the development and implementation of corrective and preventative actions.
• Collaborate with other Novartis Global Line Functions across Divisions, including Patient Safety Alliance, EU QPPV, medical affairs and marketing to ensure implementation of CAPA and fulfilment of the safety requirements as well as CMO&PS Technology, Systems & Innovation group to develop new tools & methodologies.
• Escalation to CMO&PS leadership and appropriate internal functions and/or External Service Providers (ESPs) of compliance/quality issues. Represent CMO&PS externally as a subject matter expert on compliance and quality Train and mentor new CMO&PS associates and associates from other line functions
• Develop and implement quality and compliance metrics for new safety case management and aggregate reporting processes, working with the process/metrics owners, Quality Assurance and other line functions as appropriate. Lead projects to optimize processes used to monitor the quality of safety cases and aggregate reports as well as internal and regulatory compliance:
• Develop and maintain tools to assist in the monitoring of quality and compliance, intro-ducing 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 internal 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 in to Novartis standards as appropriate. Manage assigned monitoring activities / metrics production:
Lead investigations in to any defi-ciencies identified, develop and implement corrective and preventative actions (CAPAs) and measuring the effectiveness of these.
• Act as a subject matter expert on assigned quality and compliance monitoring activities and met-rics during audits and inspections.
• Act as a subject matter expert during audits and inspections, lead the preparation of responses to findings and the development and implementation of corrective and preventative actions.
• Collaborate with other Novartis Global Line Functions across Divisions, including Patient Safety Alliance, EU QPPV, medical affairs and marketing to ensure implementation of CAPA and fulfilment of the safety requirements as well as CMO&PS Technology, Systems & Innovation group to develop new tools & methodologies.
• Escalation to CMO&PS leadership and appropriate internal functions and/or External Service Providers (ESPs) of compliance/quality issues. Represent CMO&PS externally as a subject matter expert on compliance and quality Train and mentor new CMO&PS associates and associates from other line functions
Candidate Profile
PharmD, MSc degree in life sciences or equivalent Fluency in English. Knowledge of other languages desirable
• Minimum 4 years of experience in the pharmaceutical industry, particularly pharmacovigilance
• Experience in project management and demonstrated ability to lead work groups
• 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 environment and across functions
• Strong analytical skills
• Quality focus
• Ability to mentor and coach
PharmD, MSc degree in life sciences or equivalent Fluency in English. Knowledge of other languages desirable
• Minimum 4 years of experience in the pharmaceutical industry, particularly pharmacovigilance
• Experience in project management and demonstrated ability to lead work groups
• 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 environment and across functions
• Strong analytical skills
• Quality focus
• Ability to mentor and coach
Additional Information
Experience : 4 years
Qualification : Pharm.D, M.Sc
Location : Hyderabad, AP
Industry Type : Pharma
Functional Area : R&D
End Date : 10th March, 2019
Experience : 4 years
Qualification : Pharm.D, M.Sc
Location : Hyderabad, AP
Industry Type : Pharma
Functional Area : R&D
End Date : 10th March, 2019
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