REQ-10008877
Mag 27, 2024
Malaysia

Summary

The Regional Head PV QA drive quality oversight for implementation and maintenance of Novartis Pharmacovigilance (PV) Patient Safety Quality Management Systems performed by local teams within assigned Novartis regions and country organizations, ensuring compliance with applicable local and global regulatory requirements and Novartis procedures as well as escalation of issues.

About the Role

Your Responsibilities:

Your responsibilities include, but not limited to:

  • Drive independently the regional and country quality oversight for implementation and maintenance of Novartis Pharmacovigilance Quality Systems performed by the local teams, namely documentation, training, deviation and action management systems.
  • Ensure together with PS Countries and regions team that regional and country quality performance of the Novartis PV System tasks and responsibilities as required under global, regional and country PV regulations is performed to monitor that safety of Novartis authorized products are met and changes to their risk-benefit balance are identified.
  • Support the Research and Development Quality management cycle through development, execution and accountability for deliverables of the global Pharmacovigilance Quality Plan (QP). Coordinate execution of the QP with relevance to applicable regional and country patient safety and PV relevant functions and report the status to applicable Global CMO and Patient Safety QA team.
  • Establish and monitor indicators that relate to the performance, compliance and quality of regional and country pharmacovigilance systems in line with indicators defined by Global CMO and Patient Safety QA team; Promptly communicate regional and country compliance issues to Global CMO and Patient Safety QA 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 within and across regions. Lead regional initiatives focused on quality improvement and compliance, provide ongoing project support and governance, as assigned.
  • Support Global CMO Patient Safety QA team in the execution of Pharmacovigilance Quality Risk Assessments (QRA) to identify and mitigate regional and country PV risks.
  • Ensure a constant state of regional and country inspection readiness. In line with Global CMO Patient Safety QA team, prepare for, facilitate and lead logistics for Health Authority (HA) Pharmacovigilance inspections, assess results of pre-inspection activities and HA inspection findings in terms of associated risks and communicate to management. Align with PS team and other Business Partners and review corrective and preventive (CAPA) plan to ensure quality, consistency and appropriateness of commitments. Monitor status of CAPAs to ensure they are completed, appropriately documented and sustainable.
  • Drive facilitation and follow-up of PV audits and assist with development of robust and sustainable CAPAs. Monitor the status of CAPAs to ensure they are completed, appropriately documented and sustainable.
  • Support Patient Safety and other business partners with compliance and Quality Issue investigations and ensure timely escalation to management; provide assistance in the remediation of PV system issues; ensure follow-up and monitoring of completeness of CAPAs in alignment with Global CMO Patient Safety QA team.
  • Oversee definition of self-inspection plans to regional and country pharmacovigilance processes as well as their execution.
  • Identify regional and local training needs and coordinate/facilitate implementation of training programs that meet the needs of business partners and improve overall quality and compliance.
  • Deputize for Global Head CMO and Patient Safety QA, Regions and Countries or other team member as required.

What you’ll bring to the role:

  • Five plus years quality/ PV/ clinical/ regulatory affairs/ pharmaceutical industry/ health authority experience;
    • GCP/PV/GMP auditing or inspection experience and Heath Authority interactions a plus;
    • Experience in PV in a country organization and global quality support to stakeholders in country organizations a plus;
    • Extensive knowledge of PV regulations, guidelines and policies;
     

Why Novartis?

Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us!

Learn more here: https://www.novartis.com/about/strategy/people-and-culture

Commitment to Diversity and Inclusion:

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Development
Pharmaceuticals
Malaysia
Selangor
Quality
Full time
Regular
No

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

careers default image
REQ-10008877

Regional Head PV QA

Apply to Job