Site Name: UK - Hertfordshire - Stevenage, Home Worker - USA, Philadelphia Navy Yard, RTP, Upper Providence, Waltham
Posted Date: Feb 3 2023
359919 CAPA Manager, Pharmacovigilance QA – 9-12 month Secondment/Fixed Term Contract
The purpose of this role is to provide support to the Pharmacogivilance Quality Assurance (PVQA) team on either a secondment or fixed term basis (as maternity leave coverage). This role will primarily manage Corrective and Preventative Actions (CAPAs) for the PVQA team arising from Audits, Inspections and Significant Quality Issues (SQIs). In addition, other Quality Management System (QMS) activities will be in scope such as supporting management monitoring/ self-inspection, PVQA written standards, archiving and information strategy/management. While in this role, the individual will also gain exposure to audits and inspections through observation and support as well as support special projects.
In this role you will
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Assist in the development, management, and implementation of activities to support the global pharmacovigilance QA audit program
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Support delivery of PVQA audit programme
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Partner with business contacts within GSK Central Safety (Pharmaceuticals, Vaccines and ViiV) and Local Operating Companies
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Ensure staff are prepared for regulatory agency inspections by providing support as required
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Support Global Regulatory Inspections
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Support management monitoring activities within PVQA
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Contribute to assessing adherence to quality standards and compliance with applicable regulations and guidelines, and GSK policies and procedures. Support planning and conduct of audits of PV activities within Global Safety, LOCs, External Service Providers, Licensing Partners to assure compliance with regulations, GSK policies and procedure, and applicable local regulations
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Primary internal customer base will include Global Safety, LOCs, Risk Management, QPPVs, GRA
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Support regulatory inspections for related regulatory authority inspections of GSK
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Assist and contribute to development of periodic reports and other information to identify trends and develop improvements across the business
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Build and maintain beneficial working relationships with all internal and external customers
Closing Date for Applications: February 19th, 2023 (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.
During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process. If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements, please contact 0808 234 4391. This will help us to understand any modifications we may need to make to support you throughout our selection process.
Why you?
Qualifications & Skills:
We are looking for professionals with these required skills to achieve our goals:
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Bachelor’s degree in related Life Science, Pharmacy, or related discipline. Equivalent experience will be considered
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A broad scientific/pharmaceutical industry background with relevant experience in pharmaceutical research and drug safety
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Good Pharmacovigilance Practice Compliance, Good Clinical Practice Compliance and/or Quality Assurance or Quality Management System; Drug Development experience
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Knowledge of the drug/clinical development processes and R&D Systems
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Self-motivated and quick learner who proactively shares knowledge and welcomes knowledge and feedback from other team members
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Ability to work independently and make decisions with minimal supervision
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Must have a high degree of organizational awareness and working towards resolution with complex problems
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Have demonstrated project management skills and management of complex cross-functional activities
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Have demonstrated ability for good verbal, written and presentation skills
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Potential for travel (up to 25%)
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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.
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.
Find out more:
Annual Report 2021
We’re combining the power of genetic and genomic insights into what causes disease, with the speed and scale of artificial intelligence and machine learning (AI/ML) to make better predictions about who a treatment might work for, and why. We believe this powerful combination of data and technology holds the key to fundamentally transforming medical discovery for the better, improving R&D success rates and shaping how even the most challenging diseases, like neurological conditions and cancer, can be both prevented and treated.
In 2021 we delivered four major product approvals: Cabenuva for HIV, Jemperli for endometrial cancer, Xevudy for COVID-19 and Apretude, our new long-acting medicine for HIV prevention.
Find out more:
Our approach to R&D
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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.
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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.
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 [email protected] or 0808 234 4391. Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels
As 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.
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