Novartis PV Compliance
and Quality Manager PharmD, MSc degree in life sciences or equivalent. Fluency
in English
Job Description
Your responsibilities include, but are not limited to:
• 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 in to 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 ensure implementation
of CAPAs and fulfilment 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.
Minimum requirements
• PharmD, MSc degree in life sciences or equivalent. Fluency
in English. Knowledge of other languages desirable.
• Minimum 4 to 7 years of experience in the pharmaceutical
industry, particularly pharmacovigilance
• Experience in project management and demonstrated ability
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 environment and across
functions
• Strong analytical skills, Quality focus and ability to
mentor and coach
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