Principle Scientist or Manager, PV Operations

ENGINEERINGUK; London; On-site; GBP 50,000 - 90,000; Full time

Job summary

An established industry player is looking for a dedicated professional to support Pharmacovigilance Operations with a focus on Individual Case Safety Report (ICSR) Management. This role offers the opportunity to oversee critical processes, interact with Local Operating Companies, and ensure compliance with regulatory standards. The ideal candidate will contribute to enhancing ICSR management methodologies and lead a team in delivering high-quality safety data reporting. This position promises a dynamic work environment where your expertise will directly impact patient health and safety, making a significant difference in the biopharma sector.

Qualifications

• Degree in life sciences or equivalent experience required.
• Strong knowledge of pharmacovigilance systems is essential.

Responsibilities

• Oversee ICSR processing and ensure compliance with regulatory standards.
• Manage clinical trial interactions from setup to closeout.

Skills

Project Management

Process Mapping

Pharmacovigilance Systems Knowledge

Training Development

Mentoring Skills

Education

Degree in Life Sciences

Medically Related Field Experience

Job description

Principle Scientist or Manager, PV Operations

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

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.

In this role you will:

• 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)

Basic Qualifications & Skills:

• 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:

• 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.

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).

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).