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Job Title: QA Director, Pharmacovigilance
Location: GSK HQ, London
Overview
GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. We are on an audacious journey to impact the health of 2.5 billion people over the next decade. Our R&D division is at the forefront of this mission, dedicated to the discovery and development of groundbreaking vaccines and medicines. We are transforming the landscape of medical research by integrating cutting-edge science and technology and harnessing the power of genetics and new data. By fostering a collaborative environment that unites the talents of our people, we are revolutionizing R&D to pre-empt and defeat diseases. Join us in our commitment to uniting science, technology, and talent to get ahead of disease together.
Role Overview
GSK are looking for a Pharmacovigilance QA Director to join the team in GSK HQ in London. This person will maintain a Pharmacovigilance quality assurance programme to ensure that the pharmacovigilance system supporting VH products is compliant with pharmacovigilance legislation and company policies and procedures.
Key Responsibilities
- Provide assurance to VH that processes for managing safety data are effective in ensuring the integrity of data, compliance with VH policies and procedures, regulatory requirements, and the protection of patients.
- Educate and engage VH senior management to understand key risk areas and the PV universe, identify key quality and compliance risks, and obtain agreement on remedial plans to address these risks.
- Manage the VH PV QA programme, including audit risk assessment, audit planning and scoping, oversight of independent PV audits, tracking VH-initiated PV CAPAs to resolution, monitoring GSK CAPAs and escalating issues as required, and ensuring VH staff are prepared and supported during internal audits.
- Provide oversight of audit outputs from GSK GQA as they impact VH products.
- Maintain knowledge of the Service Provider PV model to ensure that risks to VH products are identified and addressed through audit or other activities.
- Manage inspections for PV-related aspects of GCP inspections and post-marketing PV inspections, ensuring all staff required to support inspections are sufficiently prepared.
- Collaborate with VH personnel to ensure that deviations and exemptions from VH written standards are managed and documented in alignment with regulatory requirements.
- Maintain audit and deviation data on the VH Pharmacovigilance System Master File.
- Generate and provide metrics, status and periodic reports, and other information to monitor the performance of the PV QMS.
- Provide appropriate input relating to the risks associated with the PV Quality Management System into VH governance and oversight meetings, and meetings with the Service Provider.
- Provide expert advice in relation to compliance, quality improvement, process and programme initiatives and risk assessment, and act as a point of contact for customers.
- Assist in the development of the existing QMS which underpins VH PV activities to ensure systems and processes are in alignment with legislative requirements.
- Maintain an up-to-date and in-depth knowledge of appropriate national and international PV/GCP legislation and guidelines, as well as VH/GSK procedures that affect the business.
- Advise VH management, PV, of implications and collaborate with VH management, PV, to interpret international regulations and guidelines and establish and monitor compliance for acceptable standards for PV activities.
- Develop and maintain a network of contacts within VH and GSK quality and compliance groups, as well as external resources.
- Assist in developing, supporting and maintaining customer training programmes and help deliver training within area of expertise.
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Skills and Qualifications
- BSc or equivalent required.
- Up-to-date and in-depth knowledge of appropriate national and international PV/GCP legislation and guidelines.
- Knowledge of VH/GSK procedures that affect the business.
- Experience maintaining a Pharmacovigilance quality assurance programme.
- Experience managing PV audits, audit risk assessments, audit planning and scoping.
- Experience tracking CAPAs through to resolution and verifying effectiveness.
- Experience supporting PV-related aspects of GCP inspections and post-marketing PV inspections.
- Strong understanding of PV Quality Management Systems and regulatory requirements.
- Ability to identify key quality and compliance risks and agree remedial plans to address these risks.
- Ability to provide expert advice in relation to compliance, quality improvement, process and programme initiatives and risk assessment.
- Ability to educate and engage senior management on key risk areas and PV quality and compliance matters.
- Experience developing and maintaining networks across quality and compliance groups and external resources.
Why GSK?
Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
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Inclusion at GSK
GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. If you need any adjustments in the recruitment process, please get in touch with our Recruitment team (EMEA-GSKLink@allegisglobalsolutions.com) to further discuss this today.
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