Manager, Medical Governance -QPPV office

Please Note (Grade of role):The role is considered Grade 7 or Grade 6 (depending on the qualification(s), experience and competency of the successful applicant). This will be discussed at interview-stage

‘Be You’ at GSK

At GSK, we’re a company with a purpose to help people do more, feel better and live longer. We realise that our purpose starts with us. When we feel at our best, we perform at our best. Therefore, we want all applicants to be able to perform their best throughout the recruitment process. We will be delighted to hear from talented individuals that align to our values. These are at the heart of everything we do and include: Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork.

When you set out on your adventure at GSK, we make a deal. You commit to living our values and expectations and performing against our Innovation, Performance and Trust priorities. In return, GSK commits to providing the right environment for you to thrive. Together, we build an environment where we can all thrive and focus on what matters most to each of us. As a modern employer, we empower you to be yourself, share ideas and work collaboratively.

GlaxoSmithKline is a world leading research-based pharmaceutical company that combines both individual talent and technical resources to create a platform for the delivery of strong growth in a rapidly changing healthcare market. Our mission is to improve the quality of human life by enabling people to do more, feel better and live longer.

In this position you will have a role in Safety Governance including support for QPPV office activities and help ensure GSK QPPV oversight of the Pharmacovigilance Systems and its Quality System.Of the two available roles one will have a focus on managing the process and compilation of the GSK PSMF including EU, Global and templates for local use. The PSMF role also includes supporting local markets especially for first PSMF.

These roles also involve knowledge of regulations, coordination of stakeholder responses and ability to support inspection requests including interviews on purpose and maintenance process for the QPPV office activities and /or PSMF.

Key Responsibilities include, but are not limited to:

• Ensure the GSK QPPV oversight of the entire PV system and processes with responsibility for execution of an effective process to meet legislative requirements in close collaboration with the other QPPV office members.
• For PSMF focussed role: Management of the GSK Pharmacovigilance System Master File, the Summary of the PV System and associated documents
• Liaison with cross-functional stakeholders and subject matter experts to coordinate collection and collation of information for EU QPPV oversight/ EU PSMF updates and ensure process quality and promote data quality.
• Maintain an awareness of changes and updates to the global PV system by nurturing a network of contacts and being a highly visible and proactive ambassador. Maintains a good understanding of the global pharmacovigilance system (Central and Local) and the typical interfaces within pharmacovigilance in order to facilitate the oversight of the PV system/ accurate maintenance and development of the PSMF.
• Identify areas for ongoing improvement of the QPPV office/ PSMF and PSMF process. Input into strategic discussions to improve the collection and collation of data for the oversight of the PV system/ PSMF and implement outcomes to achieve continuous improvement
• Good knowledge of European Union (EU) legislation defined for the EU QPPV/ PSMF. Responsible for maintaining a detailed awareness of global legislation and other publicly available information affecting PV system oversight/the PSMF and for communicating this to appropriate people within and outside of the group.
• Provision of data/ PSMF and additional support including responding to requests and interview attendance for central and local regulatory inspections
• Responsible for providing guidance and practical support to non-EU LOCs when legislation requires a local QPPV/ PSMF to be developed. A non-EU PSMF template has been developed and will need to be maintained
• Maintenance of relevant documentation e.g. the PSMF SOP, archiving of documentation to support the PSMF process and training stakeholders and subject matter experts on updates to the PSMF process.

Please take a copy of the Job Description, as this will not be available post closure of the advert.

When applying for these roles, 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.

• LI-GSK

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• BSc with relevant experience in the area.
• Experience of writing or coordinating information collection/ documents with multiple contributors to provide seamless quality output
• Have sufficient insight into the PV system to understand data provided is accurate and consistent with existing information and contributions from others
• Post holder will interact with many different functions across GSK organization as well as with external stakeholders; position holder needs to understand intimately the business needs and operating environment across the broader GSK organisation; legislation is complex and continually evolving.

Preferred Qualifications:

• Master or equivalent professional experience
• Pharmacy, Chemistry, Bio Engineer, Biology, Medical Doctor, Bio Medical Sciences
• Pharmacovigilance or Medical Governance experience is an asset

Why GSK?

GSK is a place where outstanding people do amazing things. As a science-led global healthcare company, we exist to help people do more, feel better, live longer. This special purpose – along with our goal of being one of the world’s most innovative, best performing and trusted healthcare companies – helps us attract some of the best and brightest minds in the world.

We take pride in providing access to all and continually focus on our opportunity and obligation to do more to improve inclusion and diversity: for our people inside GSK; in the way we do business; and in the communities where we operate.

We want our company to be a place where diversity of people and thought is valued everywhere and where we’re all able to be ourselves and feel a sense of belonging. An inclusive organization where we all feel valued, engaged and supported, knowing that our work makes an important contribution to our mission. Reinforced by our clear values and expectations, it is part of our DNA. Together we achieve extraordinary things for our patients and consumers, who rely on us each and every day.

As a company driven by our values of Patient focus, Transparency, Respect and Integrity, we know inclusion and diversity are essential for us to be able to succeed. We want all our colleagues to thrive at GSK bringing their unique experiences, ensuring they feel good and to keep growing their careers. As a candidate for a role, we want you to feel the same way.

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 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.

Please don’t hesitate to contact us if you’d like to discuss any adjustments to our process which might help you demonstrate your strengths and capabilities. You can either call us on 0808 234 4391, or send an email ukdiversity.recruitment@gsk.com

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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