Principal Scientist, PV Operations / Manager, PV Operations

Principal Scientist, PV Operations / Manager, PV Operations

The key purpose of this role is to support Pharmacovigilance Operations “PV Ops”– ICSR Management. Depending on candidates’ level of experience, this position may be considered at either the Principal Scientist or Manager level.

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

• Support Scientists with enhancement of knowledge and skills for ICSR Management activities
• Leads and oversees 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.
• Acts 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.
• Generates new ideas and proposals for global implementation; contributes to advancement of ICSR management/ program/clinical trial set up/maintenance methodology and processes.
• Prioritize work and time management, in line with business needs.
• 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 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.
• Ensures third parties/vendors develop and implement robust processes to support quality-driven organization.
• In addition, at the “Manager” Level:
  • People lead, providing development opportunities and capability building, provide guidance and direction to the team to achieve objectives; and/or
  • 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.
• End-to-end case processing knowledge, from intake to submissions.
• In-depth knowledge of pharmacovigilance (PV) concepts and project management within PV, including regulatory requirements, documentation, process design, implementation, and written standards.
• Experience in clinical trials from a PV perspective (not just general clinical trial roles like CRA), or post-marketing PV; candidates with only one area may be considered for a suitable team fit.
• Experience in PV project management/oversight task

Preferred Qualifications & Skills:

Please note the following skills are not necessary, just preferred, if you do not have them, please still apply:

• Technological experience, such as working on automation or AI projects, rolling out new technology, or serving as an SME in such initiatives.
• Ability and willingness to adapt to new technology and automation trends in PV.

Closing Date for Applications – 23rd of December, 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 by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together.

Find out more:  

Our approach to R&D.   

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

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.

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