Regional Head, Pharmacovigilance Quality (PVQA)

GB16 (FCRS = GB016) Novartis Pharmaceuticals UK Ltd.; Greater London; Hybrid; GBP 64,000 - 119,000; Full time

Benefits offered by this job

Hybrid working options

Competitive benefits

14 weeks parental leave

Job summary

Novartis Pharmaceuticals UK Ltd. in London is seeking a Regional PV QA Head to lead end-to-end quality assurance vigilance activities for local and regional PV and device vigilance, ensuring compliance with regulatory requirements and Novartis procedures.

The role drives quality oversight for country operations, leads CAPA planning, and collaborates with Global PV QA to maintain inspection readiness. The ideal candidate has PV and QA leadership experience, strong knowledge of GMP/GVP

Qualifications

• Degree in Life Sciences or related scientific discipline.
• Higher degree desirable.
• Excellent written and verbal English communication skills.
• Quality/PV/clinical/regulatory affairs experience; auditing/inspection experience a plus.
• Experience in PV in a country organization with global quality support a plus.
• Ability to travel up to 20%.
• Ability to independently manage complex compliance issues with minimal supervision.
• Quality mindset and strong leadership and facilitation skills.
• Extensive knowledge of PV regulations, guidelines and policies; GCP/Part 11 awareness.
• Ability to work across diverse teams and cultures.

Responsibilities

• Drive regional and country quality oversight for implementation and maintenance of vigilance quality systems.
• Ensure regional and country quality performance aligns with PV regulations and safety requirements.
• Support the Global Research and Development Quality management cycle with deliverables from the global vigilance plan.
• Coordinate execution of the vigilance plan and report status to Global PV QA.
• Monitor indicators related to performance, compliance and quality of PV systems.
• Act as a quality champion by communicating risks and proposing mitigations.
• Communicate compliance issues to Global PS&PV and QPPV, escalate as needed.
• Lead regional quality improvement initiatives and governance activities.
• Provide expertise for vigilance quality risk assessments and CAPA planning and execution.
• Support maintenance of the global Pharmacovigilance System Master File (PSMF).
• Ensure readiness for inspections and lead inspection activities with HA where applicable.
• Review CAPA plans and approve related evidence in the QMS.
• Guide development of robust CAPAs addressing PV audit findings.
• Oversee quality issue investigations and timely escalation to management.
• Oversee self-assessment plans and review reports for PV processes.
• Identify training needs and deliver knowledge-sharing sessions.

Skills

Quality Assurance

PV Regulations

GCP/GMP Auditing

English Communication

Stakeholder Management

Travel up to 20%

Education

Bachelor's degree in Life Sciences

Higher degree desirable

Job description

Job Description Summary #LI-Hybrid

Salary Range: £63,917.00 - £118,703.00

Location: London, UK

This role is based in London, UK. Novartis is unable to offer relocation support for this role. Please only apply if this location is accessible for you.

Job Description

The Regional PV QA Head provides end to end quality assurance vigilance expertise and support to global and local operational Pharmacovigilance (PV) and Device Vigilance activities within Novartis with a focus on the country organizations, as well as quality expertise in regional and local vigilance regulation, in order to ensure compliance with applicable regulatory requirements and Novartis procedures.

Major Accountabilities:

• Drive independently the regional and country quality oversight for implementation and maintenance of Novartis vigilance Quality Systems performed by the local teams, namely Quality Issue, proactive risk assessment and action management systems.
• Ensure, together with PS and PV in Countries and Regions team, that regional and country quality performance of the Novartis Vigilance System tasks and responsibilities is performed as required under global, regional and country PV regulations, to monitor that safety of the Novartis authorized products are met, and changes to their risk-benefit balance are identified.
• Support the regional and country Global Research and Development Quality management cycle through development, execution and accountability for deliverables of the global vigilance Quality Plan (QP).
• Coordinate execution of the QP with relevance to applicable regional and country patient safety activities and report the status to applicable Global PV QA team.
• Monitor indicators that relate to the performance, compliance and quality of regional and country vigilance systems, in line with indicators defined by Global PV QA team.
• Act as a quality champion by communicating risks to PS and PV and providing recommendations on potential mitigations.
• Promptly communicate regional and country compliance issues to Global PS&PV, PV QA management and QPPV.
• 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.
• Provide expertise and support Global PV QA team in the execution of vigilance Quality Risk Assessments (QRA) to identify and mitigate regional and country PV risks.
• Support maintenance of the Novartis global Pharmacovigilance System Master File (PSMF), where applicable.
• Ensure a constant state of regional and country vigilance inspection readiness.
• In line with Global PV QA and PS&PV teams, prepare for, facilitate, provide expertise and lead logistics for Health Authority (HA) vigilance inspections, assess results of pre-inspection activities and HA inspection findings in terms of associated risks and communicate to management.
• Perform Quality check of vigilance inspection deliverables.
• Align with PS and PV team and review the inspection corrective and preventive (CAPA) plan, to ensure quality, consistency and appropriateness of commitments.
• Act as the functional QA approver of inspection CAPA plans from the PV inspections in country organizations in the QMS.
• Monitor the status of implementation of the CAPAs and approve the related evidence in the QMS, to ensure they are completed, appropriately documented and sustainable.
• Expertly guide the development of robust and sustainable CAPAs to address PV audit findings related to country organizations and act as functional QA approver of the CAPA plan in the QMS.
• Monitor the status of implementation of CAPAs to ensure they are completed, appropriately documented and sustainable and approve applicable related evidence in the QMS.
• Provide expertise and support country PS and PV and other business partners with identification and compliance of-Quality Issue investigations, act as functional QA in the QMS and ensure timely escalation of applicable Quality Issues to management; provide assistance in the remediation of PV system issues; ensure follow-up and monitoring of completeness of CAPAs in alignment with PV QA team.
• Oversee definition of PV self-assessment plans from Regional PS & PV team to regional and country pharmacovigilance processes as well as their execution.
• Review vigilance self-assessment reports and approve related action plans in the QMS.
• Identify regional and local training needs (for example via Quality Issues) and deliver knowledge sharing sessions that meet the needs of business and QA partners and improve overall quality and compliance of the Vigilance system.
• Provide guidance and recommendations on Merger & Acquisition as well as divestment relevant activities for integration or disintegration of the vigilance system, where applicable.
• Lead and/or support due diligence (DD) activities for potential product and/or company acquisitions, when applicable.

Minimum Requirements:

• Degree in Life Sciences or related scientific discipline.
• Higher degree desirable.
• Excellent written and verbal English communication skills; fluency in a second language a plus.
• Quality/ PV/ clinical/ regulatory affairs/ pharmaceutical industry/ health authority experience; GCP/PV/GMP auditing or inspection experience and Health Authority interactions a plus.
• Experience in PV in a country organization and global quality support to stakeholders in country organizations a plus.
• Ability to travel up to 20%
• Ability to independently manage and objectively evaluate complex compliance issues with minimal supervision; Excellent problem solving, decision making and prioritization skills.
• Quality mindset and excellent quality and compliance leadership and facilitation skills.
• Extensive knowledge of PV regulations, guidelines and policies; Awareness of GCP and Part 11 requirements.
• Ability to lead teams and operate successfully in various team capacities and diverse cultural environments.
• Ability to deputize for the Global Head PV QA Regions and Countries as needed.

Benefits & Rewards

• Expected Annual Base Salary Range for role: 63,917.00 - 118,703.00 GBP
• The base salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically.
• In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters.
• The rewards of being part of our team go far beyond base pay and incentives.
• We also offer a variety of competitive benefits in kind to help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeing resources and global recognition programs.
• In addition, we provide flexible and hybrid working options, where possible, and minimum 14 weeks paid parental leave.
• Read our brochure to learn more about our global total rewards offering: https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf

Skills Desired

Business Acumen, Business Partnerships, Change Management, Communication, Continuous Improvement, Data Integrity, Digital Fluency, Ensure Compliance, GMP Operations, Good Laboratory Practices (GLPs), Good Manufacturing Practices (GMP), Leadership, Managing Ambiguity, Organizational Savvy, Problem Solving, Process Improvements, Quality Assurance (QA), Quality Compliance, Quality Management, Quality Management Systems (QMS), Regulatory Compliance, Risk Management, Stakeholder Management, Storytelling

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