Manager, Pharmacovigilance Quality Assurance

Major Accountabilities:

• Support initiatives to maintain or improve quality performance and compliance of Novartis PV activities including case processing, medical safety, risk management, Health Authority reporting, PV IT systems and device vigilance.  Champion the quality mindset.
• Support initiatives focused on quality, process, and compliance improvement.  Through close collaboration with business partners, identify opportunities and develop strategies aimed at simplifying processes and improving quality while ensuring compliance with applicable regulatory requirements.
• Provide quality support of transition and integration-related activities for PV and Device Vigilance systems resulting from mergers, acquisitions, and/or divestments.
• Support maintenance of the Pharmacovigilance System Master File (PSMF).
• Support training initiatives as assigned.
• Provide quality support to PS&PV and other groups/business partners involved in PV and DV activities; assist with issue identification and root cause investigations; sign-off investigation reports. 
• Support Health Authority Inspections, including inspection readiness activities, conduct, and follow-up.
• Guide the development of robust and sustainable corrective and preventative action plans (CAPA) in collaboration with the responsible groups performing PV and DV activities.  Monitor status of corrective and preventative actions to ensure the issues are adequately addressed, completed, and appropriately documented.
• Ensure quality and regulatory compliance issues are promptly communicated to appropriate management. Support initiatives geared towards remediation of compliance concerns; determine effectiveness of remediation activities; provide ongoing project support and governance.

Minimum Requirements:

• A minimum of two years PV/PV quality and related pharmaceutical industry and/or Health Authority experience; Device vigilance experience a plus.
• PV auditing or inspection experience and Health Authority interactions.
• Experience in maintenance of PV and/or device Quality Management Systems       
• Ability to manage and objectively evaluate compliance issues with limited supervision; good problem solving, decision making and prioritization skills.
• Quality mindset.
• Good knowledge of PV regulations, guidelines, and policies; awareness of GCP and Part 11.
• Ability to operate cross-functionally and in diverse cultural environments.

Languages:

• Excellent communication skills with good written and verbal command of English and fluency in at least one other language.

Adjustments for Applicants with Disabilities:

The law provides for severely disabled / equal applicants the opportunity to involve the local representative body for disabled employees (SBV) in the application process. If you would like to request this, please let us know in advance as a note on your CV.

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