Principle Scientist or Manager, PV Operations

WISE Campaign; London; Hybrid; GBP 45,000 - 75,000; Full time

Job summary

An established industry player is seeking a dedicated professional to support Pharmacovigilance Operations with a focus on Individual Case Safety Report Management. This role involves overseeing case processing, interacting with Local Operating Companies, and managing clinical trial interactions. The ideal candidate will ensure compliance with GSK standards and regulatory timelines while fostering effective processes for vendor oversight. This position offers a competitive salary, annual bonuses, and a hybrid working model, making it a great opportunity for those looking to thrive in a supportive and innovative environment.

Benefits

Healthcare and Wellbeing Programmes

Pension Plan Membership

Shares and Savings Programme

Annual Bonus based on Company Performance

Qualifications

• Degree in life sciences or related field required.
• Project management experience and knowledge of pharmacovigilance systems.

Responsibilities

• Oversee processing of ICSRs and case management activities.
• Collaborate with stakeholders to ensure compliance with safety data reporting.

Skills

Project Management

Process Mapping

Pharmacovigilance Systems Knowledge

Education

Degree in Life Sciences or Medically Related Field

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 in-office work.

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.
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.

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.