Principal Scientist or Manager, PV Operations
Job Title: Principal Scientist or Manager, PV Operations
Location: London, United Kingdom; Wavre, Belgium
Job Function: Medical and Clinical
Job Type: Full-time
Reference ID: 419243
Why Us:
At GSK, we aim to create an environment where people grow, feel valued, and are inspired to be their best. We offer competitive salaries, annual bonuses, healthcare and wellbeing programs, pension plans, and shares and savings programs. Our hybrid working model, "Performance with Choice," empowers you to find the optimal balance between remote and in-office work.
What We Do:
We unite science, technology, and talent to get ahead of disease together. We are committed to transforming the health of 2.5 billion people in the next decade by discovering and delivering transformational vaccines and medicines through strong tech-enabled capabilities and deep biological insights.
How We Do It:
By focusing on the science of the immune system, investing in new platform technologies, and fostering a culture where people feel welcome, included, and able to thrive. We focus on four core therapeutic areas: infectious diseases, HIV, respiratory/immunology, and oncology.
Job Description:
We are seeking a dedicated professional to support Pharmacovigilance Operations (PV Ops), primarily focusing on Individual Case Safety Report (ICSR) Management. Based on the successful candidate’s experience, the position will be appointed as Principal Scientist, PV Ops or Manager, PV Ops.
The role involves overseeing case processing, coding conventions, clinical trial interactions, market authorizations, withdrawals, and PAC awareness, ensuring all activities align with GSK standards and regulatory timelines.
Responsibilities:
Applicable to Both Principal Scientist and Manager Levels:
Contribute to all aspects of case handling activities from receipt to expedited reporting.
Collaborate with stakeholders (SERM group, LOCs, clinical operations) to ensure successful recording and reporting of safety data.
Work across a complex matrix environment to ensure high-quality delivery of case management activities compliant with internal and external requirements.
Facilitate investigations into root causes and create corrective/preventative actions (CAPAs) where issues are identified.
Escalate problems or issues to appropriate PV Operations management.
Generate ideas and proposals for global implementation and contribute to advancing PV Operations methodology.
Ensure third-party vendors develop and implement quality-driven robust processes.
Additional Responsibilities for Manager, PV Ops:
Support Scientists in enhancing their knowledge and skills for ICSR Management activities.
Lead and oversee activities related to Clinical Trials and Post-Marketed Studies, including protocol review, Safety Management Plan review, study setup, reconciliation, and study closeout.
Act as a global PV Operations leader in strategic process discussions and provide input into the development of written standards.
Contribute to the advancement of ICSR management methodologies and clinical trial/program maintenance processes.
Reinforce the principle of Single Point Accountability Decision Making (SPADM) within PV Ops.
Basic Qualifications:
Degree in Life Sciences or a medically related field, or equivalent professional experience.
Project management experience.
Ability to map processes and author written standards.
Knowledge and experience with pharmacovigilance systems.
Preferred Qualifications:
Experience in developing and delivering high-quality training.
Experience providing mentoring to other staff.
Additional Information:
Closing Date for Applications: 28 April 2025 (COB)
Application Tip: Use the ‘cover letter’ section of the online application or your CV to highlight how you meet the job competencies outlined above.
About GSK:
GSK is a global biopharma company with a special purpose—to unite science, technology, and talent to get ahead of disease together. We focus on preventing and treating disease with vaccines and specialty/general medicines, emphasizing infectious diseases, HIV, respiratory/immunology, and oncology.
We prioritize creating an environment where employees feel inspired, valued, included, and challenged to be their best. We are committed to agile working cultures and ensuring equal employment opportunities.
For more information about our commitment to patients, employees, and innovation, visit Life at GSK.
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