Regional Head - Pharmacovigilance Quality, Pharmacovigilance Quality Assurance
£63.9k - £118.7k/yr+ Performance-based bonus
Expert
Bachelor's, Master's
London, UK
HybridLondon-based hybrid role; travel up to 20%.
Biology & BiotechRegulatory & Quality (Life Sciences)
About the job
Requirements
- A degree in Life Sciences or a related scientific discipline is required; a higher degree is desirable.
- Excellent written and verbal English communication skills are required; fluency in a second language is a plus.
- Experience in quality, pharmacovigilance, clinical, regulatory affairs, the pharmaceutical industry, or with health authorities is required; GCP, PV, or GMP auditing or inspection experience and Health Authority interactions are advantageous.
- Experience in pharmacovigilance in a country organization and global quality support to stakeholders in country organizations is advantageous.
- Ability to travel up to 20%.
- Ability to independently manage and objectively evaluate complex compliance issues with minimal supervision, with problem-solving, decision-making, and prioritization skills.
- A quality mindset and quality and compliance leadership and facilitation skills.
- Extensive knowledge of pharmacovigilance regulations, guidelines, and policies, and awareness of GCP and Part 11 requirements.
- Ability to lead teams and work successfully in various team capacities and diverse cultural environments.
- Ability to deputize for the Global Head of PV QA Regions and Countries as needed.
Responsibilities
- Drive regional and country quality oversight for implementation and maintenance of Novartis vigilance Quality Systems by local teams, including Quality Issue, proactive risk assessment, and action management systems.
- Ensure, with PS and PV in Countries and Regions teams, that regional and country quality performance of Novartis Vigilance System tasks and responsibilities meets global, regional, and country PV regulations, monitors the safety of authorized products, and identifies changes to their risk-benefit balance.
- Support the regional and country Global Research and Development Quality management cycle through development, execution, and accountability for global vigilance Quality Plan deliverables; coordinate execution relevant to regional and country patient safety activities and report status to the applicable Global PV QA team.
- Monitor indicators of performance, compliance, and quality of regional and country vigilance systems in line with Global PV QA definitions; communicate risks to PS and PV, recommend mitigations, and promptly communicate compliance issues to Global PS&PV, PV QA management, and QPPV.
- Propose quality improvement measures and strategies to simplify processes and improve output quality while ensuring regulatory compliance; share best practices across regions and lead assigned regional quality improvement and compliance initiatives, including project support and governance.
- Support the Global PV QA team in vigilance Quality Risk Assessments to identify and mitigate regional and country PV risks, and support maintenance of the global Pharmacovigilance System Master File where applicable.
- Maintain regional and country vigilance inspection readiness; prepare for and facilitate Health Authority vigilance inspections, lead logistics, assess pre-inspection activities and findings for associated risks, communicate with management, and quality-check inspection deliverables.
- Align with PS and PV teams to review inspection corrective and preventive action plans for quality, consistency, and appropriate commitments; act as functional QA approver of country PV inspection CAPA plans in the QMS, monitor implementation, and approve evidence to ensure completion, documentation, and sustainability.
- Guide development of robust and sustainable CAPAs for PV audit findings related to country organizations; act as functional QA approver of CAPA plans in the QMS, monitor implementation, and approve applicable evidence to ensure completion, documentation, and sustainability.
- Support country PS and PV and other business partners in identifying and complying with Quality Issue investigations; act as functional QA in the QMS, escalate applicable Quality Issues to management promptly, assist in remediating PV system issues, and monitor CAPA completeness with the PV QA team.
- Oversee the definition and execution of PV self-assessment plans for regional and country pharmacovigilance processes; review vigilance self-assessment reports and approve related QMS action plans.
- Identify regional and local training needs, including through Quality Issues, and deliver knowledge-sharing sessions for business and QA partners to improve vigilance system quality and compliance.
- Provide guidance and recommendations on merger, acquisition, and divestment activities involving integration or disintegration of the vigilance system, where applicable.
- Lead or support due diligence activities for potential product or company acquisitions, when applicable.
Desired Qualifications
- Fluency in a second language.
- GCP, PV, or GMP auditing or inspection experience and Health Authority interactions.
- Experience in pharmacovigilance in a country organization and global quality support to stakeholders in country organizations.
- A higher degree.
About the company
Novartis is a global pharmaceutical company that uses science-based innovations to develop treatments and improve patient outcomes worldwide. Its products are medicines developed through research and development to address various diseases, aiming to reach nearly 1 billion people. The company differentiates itself by large-scale investment in R&D, a global presence with a diverse workforce, and a clear mission to Reimagine Medicine, focusing on meeting the changing needs of patients. Its goal is to improve quality of life and extend life expectancy by delivering meaningful therapies through its research and development efforts.
Company Size
10,001+
Company Stage
IPO
Headquarters
Basel, Switzerland
Founded
1970
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Simplify's Take
What believers are saying
- Ianalumab won FDA Breakthrough Therapy designation on January 16, 2026.
- Remibrutinib posted positive Phase III data in April 2026 and September 2026.
- The October 2, 2026 Abogen deal adds optionality across autoimmune RNA programs.
What critics are saying
- Entresto generic erosion hits in November 2026 after a September 2026 patent-loss setback.
- Reuters reported two late-stage failures in September 2026 erased nearly $30 billion.
- Novartis faces India pricing pressure over ribociclib; Kerala High Court scrutiny continues.
What makes Novartis unique
- Novartis pairs blockbuster execution with 2026 launches like Rhapsido and Itvisma.
- Its 2026 autoimmune push spans remibrutinib, ianalumab, and Abogen's ABO2203.
- CAS collaboration in September 2026 strengthens Novartis's AI-ready reaction data advantage.
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Benefits
- Health Insurance
- Dental Insurance
- Vision Insurance
- Life Insurance
- Disability Insurance
- 401(k) Retirement Plan
- 401(k) Company Match
- Paid Vacation
- Paid Sick Leave
- Paid Holidays
- Hybrid Work Options