As Associate Director, Pharmacovigilance Agreements & Safety Clauses (PVASC) you will support Pharmacovigilance Operations (PV Ops) in in alignment with GSK standards and regulatory timelines whilst driving the implementation of robust processes for successful PV operations activities, including vendor oversight.
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 webpage Life at GSK | GSK
In this role you will:
- Be responsible for PVA Database management and PVA database data entry
- Create, review and approve PVA’s and Safety clauses.
- Demonstrate technical expertise in interpretation of PV regulations, SOP/GUIs, systems/database conventions, etc.
- Identify cases of potential non-compliance with internal and external procedures. Follow appropriate procedures to investigate, identify risks, and apply- corrective actions, to prevent future issues.
- Support acquisition and divestment activities for PV Operations
- Maintain good documentation practice and be the Point of Contact in case of inspection/audit.
Why you?
Basic Qualifications & Skills:
We are looking for professionals with these required skills to achieve our goals:
- Bachelor/Master degree (scientific or medically related field preferred)
- Extensive experience in the pharmaceutical industry in clinical development, pharmacovigilance and information management or equivalent work experience.
- Knowledge of medical and drug terminology, Clinical safety and Pharmacovigilance data, or equivalent experience.
- Possesses solid/excellent computer skills and computer literacy (e-mail, Word, Excel, PowerPoint, MS Project etc.)
- Demonstrate project management skills operating in a global matrix environment.
Preferred Qualifications & Skills:
Please note the following skills are not necessary, just preferred, if you do not have them, please still apply:
- Excellent oral and written communication skills.
- Proficient in stakeholder management and customer focus
- Ability to work independently with tight deadlines while under pressure; demonstrates planning and organizational skills
- Knowledge of key pharmacovigilance regulations and methodologies
- Demonstrate a good understanding with regards to how Business Development, Commercial and Legal teams operate
Closing Date for Applications – 26 Sep 2024 (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 Ukdiversity.recruitment@gsk.com or 0808 234 4391.
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 link and scroll to the Careers Section where you will find answers to multiple questions we receive
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