Novartis
Pharmaceutical
AssociateDirector,PVQA-Data&Digital
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“Associate Director, PV QA - Data & Digital at Novartis. Skills: PVQA Data and Digital strategy and initiatives, Quality assurance oversight of end-to-end Pharmacovigilance (PV) and Device Vigilance (DV) activities, Artificial Intelligence (AI) champion, Innovation Lead. Lead PV QA Data and Digital strategy and initiatives. Drive operational excellence, and insight-driven decision-making”
What You'll Achieve.
Ensure compliance with applicable local and global regulatory requirements and Novartis procedures and quality standards; Drive operational excellence; Maintain or improve quality performance and compliance; Ensure alignment; Simplify processes and improving quality of outputs; Ensure timely escalation of applicable Quality Issues; Ensure follow-up and monitoring of completeness of CAPAs; Ensure issues are adequately addressed, completed, and appropriately documented; Ensure quality and regulatory compliance issues are promptly communicated to appropriate management; Determine effectiveness of remediation; Ensure effective quality oversight, management, and support of global PV operational vendors
Industry & Context.
Problem Solving Skills; Excellent problem solving, decision making and prioritization skills; Identification and compliance of Quality Issue investigations; Remediation of PV system; Remediation of compliance
Ability to travel up to 15%
What They're Looking For.
Must Have
Degree in Life Sciences or related scientific discipline, Five plus years PV/PV quality and related pharmaceutical industry and/or Health Authority experience, Demonstrated ability to translate quality and compliance requirements into data‑ or technology‑enabled solutions, Demonstrated ability to engage effectively with IT, Data & Digital, and Quality stakeholders, Ability to travel up to 15%, Ability to independently manage and objectively evaluate complex compliance issues with minimal excellent problem solving, decision making and prioritization skills, Quality mindset, Extensive knowledge of PV regulations, guidelines, Awareness of GCP and Part 11 requirements
Nice to Have
BAS or PharmD, PhD or other higher degree desirable, Experience with compliant development, implementation, and change management of pharmacovigilance relevant AI applications is an asset, PV auditing or inspection experience and Health Authority interactions an advantage, Experience in compliance oversight and/or procedure governance a plus
What You'll Do.
Lead PV QA Data and Digital strategy and initiatives
Drive operational excellence
and insight-driven decision-making
Maintain or improve quality performance and compliance of Novartis PV activities
Act as a quality Artificial Intelligence (AI) champion and Innovation Lead
Influence strategy and ensure alignment
Champion capability building in AI
and compliant change management
Propose potential quality improvement measures
Develop strategies aimed at simplifying processes and improving quality of outputs
Ensure compliance with regulatory share best practice and lessons learned
Lead and/or support due diligence (DD) activities for potential product and/or company acquisitions
Lead and/or support transition and integration related activities of PV and Device Vigilance systems
Support maintenance of the Pharmacovigilance System Master File (PSMF)
Ensure lessons learned and best practices are shared across the business
Provide expertise and support PS and PV and other groups business partners
Identification and compliance of Quality Issue investigations
Act as functional QA in the QMS
Ensure timely escalation of applicable Quality Issues
Provide assistance in the remediation of PV system
Ensure follow-up and monitoring of completeness of CAPAs
Support Health Authority Inspections
Guide the development of robust and sustainable corrective and preventative action plans (CAPA)
Monitor status of corrective and preventative actions
Ensure quality and regulatory compliance issues are promptly communicated to appropriate management
Lead initiatives geared towards remediation of compliance
Determine effectiveness of remediation
Provide ongoing project support and governance
Lead and execute deliverables of the Development Quality Plan
Deputize for the Team Head as needed
Ensure effective quality oversight
and support of global PV operational vendors
Drive vendor quality awareness and improvement measures
How You'll Work.
Team & Collaboration
Representing PVQA across RDQ, Quality, and PS&PV Data & Digital related networks and initiatives; Engage effectively with IT, Data & Digital, and Quality stakeholders; Collaboration with the responsible groups performing PV and DV activities; Support PS and PV and other groups business partners involved in PV and DV activities; Ensure lessons learned and best practices are shared across the business
Communication Scope
Communication Skills
Process & Methodology
Lead initiatives, Project support and governance, Development Quality Plan execution
Full Job Description
**Job Description Summary** The Associate Director, Pharmacovigilance QA - Data & Digital leads PVQA Data and Digital strategy and initiatives to support quality assurance oversight of end-to-end Pharmacovigilance (PV) and Device Vigilance (DV) activities within Novartis to ensure compliance with applicable local and global regulatory requirements and Novartis procedures and quality standards. **Job Description** **Major Accountabilities:** * Lead PV QA Data and Digital strategy and initiatives to drive operational excellence, and insight-driven decision-making to maintain or improve quality performance and compliance of Novartis PV activities including ICSR management, aggregate reporting, medical safety, risk management, Health Authority reporting, PV IT systems and device vigilance. * Act as a quality Artificial Intelligence (AI) champion and Innovation Lead representing PVQA across RDQ, Quality, and PS&PV Data & Digital related networks and initiatives, to influence strategy and ensure alignment. * By championing capability building in AI, automation, and compliant change management. proactively propose potential quality improvement measures and develop strategies aimed at simplifying processes and improving quality of outputs while ensuring compliance with regulatory requirements; share best practice and lessons learned. * Lead and/or support due diligence (DD) activities for potential product and/or company acquisitions when applicable. * Lead and/or support transition and integration related activities of PV and Device Vigilance systems resulting from mergers, acquisitions, and/or divestments. * Support maintenance of the Pharmacovigilance System Master File (PSMF). * Ensure lessons learned and best practices are shared across the business to help close learning gaps. * Provide expertise and support PS and PV and other groups/business partners involved in PV and DV activities with identification and compliance of Quality Issue investigations, act as functiona
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