Principle Scientist or Manager, PV Operations

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

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.
• Ensure 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.

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.

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 .

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