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General Electric Drug Safety Scientist in Oslo, Norway

Job Description Summary

The Drug Safety (DS) Scientist works within GE Healthcare PDx Drug Safety & Risk Management group. You will perform pharmacovigilance tasks and prepare submission-ready regulatory documents within agreed time frames and to a high standard of accuracy, in compliance with GE Healthcare business rules, standard operating procedures and global and local regulatory requirements. The DS Scientist will provide scientific support to Medical Director for safety scientific activities from clinical trials and post-marketing experience. The DS Scientist will support EU QPPV for inspection readiness. Your daily activities will involve planning, conducting meetings, database searching, aggregate safety analysis and case level review, writing, and project management/coordination of strategic safety documents. The DS Scientist will partner with team members, stakeholders including Medical Directors, QPPV and vendor(s).

GE Healthcare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.

Job Description

Roles and Responsibilities

  • Responsible for core safety deliverables including scheduled and ad hoc aggregate reports and will serve as report owner for assigned reports (medium to large volume, medium to high complexity).

  • Produce high quality, accurate and fit-for-purpose evaluation documents with clear conclusion, in response to internal or regulatory authority safety-related requests.

  • Run accurate queries and provide standard outputs of the data from the safety database; create draft reports/data tables and to perform searches of the safety database for ad-hoc queries.

  • Support preparation of RMP and post-marketing safety monitoring activities.

  • Review publications from worldwide medical/scientific literature to identify signals and applicable information for inclusion in aggregate safety reports.

  • Conduct routine and ad-hoc signal detection and evaluate safety data and signals as part of ongoing pharmacovigilance activities. This includes the ability to summarize data from multiple sources and authoring signal evaluation reports.

  • Provide support to the compilation of information for reference safety information (including Company Core Safety Information).

  • Participate and contribute to Safety Management Team meetings.

  • Support Drug safety physicians in handling issues related to both clinical and post-marketing safety, as needed.

  • In collaboration with management applies Lean strategy and leads projects for improving processes and efficiency

  • Perform other duties related to the position as necessary and as defined in SOPs and/or at the request of supervisor.

  • Serve as PV Subject Matter expert (SME) during audits and inspections in the areas of Aggregate reporting, Safety Signaling and Core label maintenance.

Required Qualifications

  • Bachelor’s or master’s degree in biologic or natural sciences; or health case discipline.

  • Pharmaceutical/biotechnology experience, including clinical trial and post-marketing pharmacovigilance experience. Global experience preferred.

Desired Characteristics

  • Ability to summarise and analyse data, experience with safety database preferred.

  • Experience in report writing (e.g. aggregate reports, responses to questions, etc.).

  • Good knowledge in FDA, EU, ICH guidelines, initiatives and regulations governing pharmacovigilance.

  • Excellent oral and written communication skills (English).

  • Excellent computer skills, in particular Microsoft Word and Excel

  • Ability to function in an environment of rapidly changing priorities and to manage multiple projects simultaneously while maintaining a high level of quality, accuracy and attention to detail.

  • Ability to act independently and to take initiative as well as work within a team. Self-starter, able to work with a high degree of independence.

Inclusion and Diversity

GE Healthcare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

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Additional Information

Relocation Assistance Provided: No

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