GlaxoSmithKline
Job title:
PV & Regulatory Oversight Manager, UK & Ireland
Company
GlaxoSmithKline
Job description
412213 PV & Regulatory Oversight Manager, UK & Ireland (Open)We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.Discover more about our company wide benefits and life at GSK on our webpageIn this role you willPharmacovigilance:Maintain local regulatory requirements for PV and MI, as appropriateOversee adherence to in-scope product EU & GB/UK Risk Management Plans and associated Risk Minimisation ActivitiesSupport creation of a compliant process for the tracking of Healthcare Professional communications (DHCPL and DIL)Supports the preparation, execution and close out of health authority inspections and internal auditsLead the cross-functional coordination required for Defective Medicines Report Centre (DMRC) responsesSupport cross-functional input required for robust QPPV oversight of the UK Pharmacovigilance SystemInput as required into Medical Governance oversight processesPerforms root cause analysis and defines robust CAPA plans for PV risk mitigationInputs into the Local Risk Register as requiredRegulatory:Support the establishment of a stakeholder network for the management of GB/UK Risk Management plans and associated activities, including continuous oversight of the UK product strategiesManage the cross-functional coordination of GB/UK Risk Management plans including GB/UK Annexes and associated activities, accountable for overall qualityLiaise with aligned departments in GSK for complex query resolution in relation to the Pharmacovigilance SystemContinually evaluate the strategic approach to regulatory activities and drive improvements to meet the changing needs of the organisation, regulatory requirements and industry best practicesManage and perform management monitoring for associated regulatory activitiesEnsure rapid communication of critical quality risks and issues and drives issue resolutionSupport monthly oversight meetings with the Local Regulatory teamsWhy you?Basic Qualifications & Skills:We are looking for professionals with these required skills to achieve our goals:Degree in pharmacy/pharmacology/relevant life science qualification or medically related degree, with a good understanding of medical and drug terminologyExperience in drug development, pharmacovigilance operations, regulatory compliance or quality managementDemonstrable experience of working with Pharmacovigilance regulationsSignificant and deep working knowledge in Pharmacovigilance methodology and strategyKnowledge of GVP, GCP, pharmacovigilance/drug safety and regulatory requirementsAbility to assimilate and interpret information relating to the field of drug safetyGood understanding of commercial business objectives and external healthcare & Pharmacovigilance environmentExperience of involvement in external regulatory inspections and auditsExperience managing key stakeholdersClosing Date for Applications – January 26th, 2025 (COB)Please take a copy of the Job Description, as this will not be available post closure of the advert.When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people over the next 10 years. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong tech-enabled capabilities that allow us to build a deeper understanding of the patient, human biology and disease mechanisms, and transform medical discovery. We are revolutionising the way we do R&D. We’re uniting science, technology and talent to get ahead of disease together.Find out more:.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.As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, 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*(*US only).We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on or 0808 234 4391. The helpline is available from 8.30am to 12.00 noon Monday to Friday, during bank holidays these times and days may vary.Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a UK Recruitment FAQ guide. Click the and scroll to the Careers Section where you will find answers to multiple questions we receiveAs you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.Important notice to Employment businesses/ AgenciesGSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK’s commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit GSK’s Transparency Reporting site.
Expected salary
Location
London
Job date
Sat, 11 Jan 2025 05:56:18 GMT
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