Principle Scientist or Manager PV Operations
Principle Scientist or Manager PV Operations
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Job Description
We are seeking a dedicated professional to support Pharmacovigilance Operations (PV Ops) with a primary focus on Individual Case Safety Report (ICSR) Management. Depending on experience of successful candidate it will be either Principal Scientist PV Ops or Manager PV Ops.
This role involves overseeing processing ICSRs and case processing coding conventions. The successful candidate will interact with Local Operating Companies (LOCs) and oversee functional vendors for market authorizations withdrawals and PAC awareness. Additionally the role includes managing clinical trial/program interactions from setup and maintenance to closeout and configuring Argus for submissions to various destinations such as regulatory authorities partners Clinical Research Organisations (CROs) LOCs and clinical operations.
The position holder will ensure all activities align with GSK standards and regulatory timelines fostering robust processes for effective PV operations and 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 inoffice work.
Discover more about our company wide benefits and life at GSK on our webpage Life at GSK GSK
In this role you will
Applicable to both Principal Scientist and Manager level
- Contribute to all aspects of case handling activities from case receipt to expedited reporting and collaborate with stakeholders (i.e. the Safety Evaluation and Risk Management (SERM) group local operating companies (LOCs) and clinical operations/sciences) to ensure that documentation and processes are in place to achieve successful recording and reporting of safety data during the life cycle of a clinical trial and marketed product.
- Work across a complex matrix environment to drive highquality delivery of case management activities that comply with internal standards and external regulatory requirements; where problems or issues are identified facilitate investigation into root cause and create corrective/preventative actions (CAPAs).
- Escalate identified problems or issues to the appropriate Management Personnel with PV Operations.
- Generate new ideas and proposals for global implementation; contribute to advancement of PV Operations methodology and processes.
- Ensures third parties/vendors develop and implement robust processes to support qualitydriven organization.
Manager PV Ops:
- Support Scientists with enhancement of knowledge and skills for ICSR Management activities
- Lead and oversee Clinical Trial and/or postMarketed study (PMS) related activities e.g. protocol review Safety Management Plan review study/program setup reconciliation end of study unblinding etc.; supports case management activities for spontaneous event reports.
- Act as a global PV Operations Leader for process discussions including queries on strategy/policy related decisions; authors or provides significant input into the development of written standards.
- Generate new ideas and proposals for global implementation; contributes to advancement of ICSR management/ program/clinical trial set up/maintenance methodology and processes.
- Act as a PV Ops leader for process discussions and changes reinforcing the principal of SPADM (single point accountability decision making)
Why you
Basic Qualifications & Skills:
We are looking for professionals with these required skills to achieve our goals:
- Degree in life sciences or medically related field or previous experience equating to educational requirements
- Project management experience
- Ability to map processes and author written standards
- Knowledge and experience with pharmacovigilance systems
Preferred Qualifications & Skills:
Please note the following skills are not necessary just preferred if you do not have them please still apply:
- Proven experience developing and delivering highquality training
- Experience of providing mentoring to other staff
Closing Date for Applications 28 April 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 techenabled 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. Were 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 its 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 0. 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 link and scroll to the Careers Section where you will find answers to multiple questions we receive
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 assured Hiring Managers do not have access to this information and we will treat your information confidentially.
Important notice to Employment businesses/ Agencies
GSK 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 GSKs 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 GSKs compliance to all federal and state US Transparency requirements. For more information please visit the Centers for Medicare and Medicaid Services (CMS) website at Experience:
Manager
Employment Type
Full-Time
Key Skills
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