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Principal Scientist, PV Operations - ICSR Management

In this role you will

The key purpose of this role is to support Pharmacovigilance Operations “PV Ops”– ICSR Management in the following activities:

• ICSR Management
  • Argus Configuration for new Programs/Studies
  • ICSR processing
  • Case Processing Coding Conventions
  • Local Operating Companies (LOC) Interactions
  • Functional Vendor Oversight:
    • New Market Authorisation
    • Withdrawal of Market Authorisation
    • PAC awareness
  • Clinical Trial/Program Interactions for:
    • Study/Program Set up
    • Study/ Program Maintenance
    • Study/ Program Close out
  • Argus Configuration for Submissions to destinations including
    • Regulatory authorities
    • Partners
    • Clinical Research Organisations (CROs)
    • LOCs
    • Clinical Operations/CROs

• 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) 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.
• Support Scientists with enhancement of knowledge and skills for ICSR Management activities
• Lead and oversee Clinical Trial and/or post-Marketed study (PMS) related activities e.g. protocol review, Safety Management Plan review, study/program set-up, 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.
• Work across a complex matrix environment to drive high-quality 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.
• Ensure third parties/vendors develop and implement robust processes to support quality-driven organization.

Closing Date for Applications: June 20th (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.

#LI-GSK

Why you?

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.
• Significant and demonstrable experience in either a Pharmaceutical, CRO or Consultancy environment working in Pharmacovigilance/Drug safety
• Proven experience developing and delivering high-quality training
• Experience of providing mentoring and/or leadership to other staff

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 positively impact the health of 2.5 billion people by the end of 2030.

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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