Principle Scientist or Manager, Pv Operations

**Site Name**: UK - London - New Oxford Street, Belgium-Wavre
**Posted Date**: Apr 14 2025

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 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

**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 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.

**Manager, PV Ops**:

- 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.
- 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 high-quality 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.

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:
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 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, inv