Manager QPPV Office

Job Description Summary

Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape!

To support the EU-QPPV and Head QPPV Office with activities required to ensure compliance with Guidelines on Good Pharmacovigilance Practices (GVP) and other applicable worldwide PV regulations and to fulfil role requirements as indicated below.

Job Description

Your Key Responsibilities:

Your responsibilities include, but not limited to:

• Ensure the end-to-end maintenance, development and submission of the UK PSMF/sPSMF and support that of the EU PSMF.
• Support the development, management and implementation of deviations and associated CAPAs across the Patient Safety organization
• Support inspection and audit operations, including CAPA development, tracking and management
• Support the development, implementation and dissemination of PS procedures
• Support QPPV in meeting legislative requirements as per relevant legislation
• Any other activities to support the QPPV office as assigned

Person specific / special tasks:

• Ensure the end-to-end maintenance of the UK PSMF working with the appropriate local and global stakeholders for the Core and Annex documents. This includes lead authoring and update of the UK PSMF, and Pharmacovigilance System Summary (sPSMF) for the pharmacovigilance system of Sandoz. This includes the management of cross-functional contributors of the Sandoz PSMF and independent identification of changes to the global PV system which require an update particularly to the UK PSMF in close collaboration with Operations Manager, QPPV Office.
• Work closely with Operations Manager, QPPV Office to ensure accurate representation of the Sandoz PV system in line with regulatory requirements and incorporate identified changes into the PSMF in a timely manner.
• Track timely provision of information from stakeholders for UK/EU PSMF production, escalating issues to the Operations Manager, QPPV Office. Format and publish final PSMF, ensuring consistency.
• Support Operations Manager, QPPV Office in provision of documents required by CPSRs to create local PSMFs / Pharmacovigilance Subsystem Files (PSSFs) as required. Support Operations Manager, QPPV Office in tracking of submission of PSMF documents as required.
• Ensure UK and EU PSMF are inspection-ready and be the key point of contact in audits and inspections for the UK PSMF and support for EU PSMF.
• Support the QSO in ensuring processes and procedures are developed on time and efficiently supporting streamlining of PV processes.
• Support Head of Audits and Inspections from preparation to CAPA implementation.
• Review process based on experience, feedback and requirements, lead continuous process improvement.

What you’ll bring to the role:

Essential Requirements:

• Eight years experience in pharmacovigilance preferably gained in a European environment within Drug Safety Department, Drug Regulatory Affairs, Clinical Development or Quality Assurance
• Good knowledge of European regulatory requirements preferentially relating to pharmacovigilance
• Pharmacovigilance systems, or similar GxP experience (covering compliance, databases, procedures, QA, training)
• Experience in the area of audits/inspections by various Health Authorities
• Proven track record of successful project management, excellent communication skills and organisational and administration skills
• Proven ability to work and handle multiple tasks independently and effectively
• Excellent negotiation, conflict resolution, decision making, problem solving, communication (written and verbal) and presentation skills.
• Results driven, self-starter with proactive working style, committed and accountable, transparent working style also under pressure.

• Excellent planning, organizational and computer skills
   

Why Sandoz?

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, provided more than 900 million patient treatments across 100+ countries in 2024 and while we are proud of this achievement, we have an ambition to do more!

With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.

Our momentum is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is supported! 

Join us!

Skills Desired

Databases, Employee Training, Pharmacovigilance, Reporting, Safety Science, Waterfall Project Management