GE Healthcare Life Sciences provides products and services used as tools for biopharmaceutical manufacturing, drug discovery and the latest in cellular technologies, thereby enabling our customers around the world to be more productive, effective and creative. Our motivation is to create better health for more people: through our five decades of supporting the biopharmaceutical industry and its research partners to become more productive, we are helping to reduce costs, increase access and improve quality in the healthcare system. We use our expertise and know-how in imaginative ways to work with our customers to provide what’s needed today and create products and solutions to enable the medical treatments of tomorrow. We add value to our customers by:
- Providing cutting-edge research tools that give deeper insights into cell function to enable disease diagnosis and the development of treatments.
- Enabling manufacturing productivity: we provide solutions for the entire bioprocess workflow (i.e. start-to-finish bioprocessing) helping our customers to develop and manufacture biopharmaceuticals more efficiently.
- Providing high quality support and maintenance services.
We are the home of many famous brands, including Whatman, Amersham, Biacore, MicroCal, WAVE, Applied Precision and more. Role Summary:
Provide medical and scientific support to both internal and external customers and respond to information enquiries and drug safety issues. The Scientific Advisor will provide support to the commercial activities, research, marketing, and safety issues within the Region consistent with legal and regulatory requirements. Essential Responsibilities:
They will have responsibility of acting as a medical/scientific expert for one or more of the company's key products with focus on contrast media for x-ray and MRI imaging and will have established their reputation outside of their region through cross functional collaboration. They will be recognized as a key partner to their commercial partners and seen as adding medical value to the business.
- Pharmacovigilance: comply with responsibilities of being Local Safety Officer, in detail:
- Full understanding of pharmacovigilance SOP with timely processing of all locally reported adverse events & forwarding to Central Safety Unit (CSU)
- All relevant communication with CSU, local customer service & QC
- Compiling & filing ADR reports, updating ADR logs, regular reporting to CSU
- Assist in safety evaluation of related product quality issues
- Updating of PV SOP, prepare files for internal & external audits on a regular bases
- Assessing & filing of E2B reports on a regular bases (E2B reporting performed by CSU)
- Training of ADR reporting obligations to Sales Force & internal staff on a regular bases
- Take over role of deputy graduate plan officer
- To be point of contact for a wide range of medical enquiries originating both internally and externally & to research and provide full answers to enquiries
- Assist in approval of promotional and other materials in accordance with appropriate regulations.
- Assist in preparation and delivery of training materials to support new staff as well as continuing training and support of the existing staff on emerging and marketed products and clinical evidence.
- Providing an additional contact point for relationships with Key Opinion Leaders.
- Involved in the dissemination of clinical paper summaries and disease area information.
- Participation at regional and national scientific meetings as requested.
- Involvement in the initiation, assessment and monitoring of investigator initiated trials (incl. budget).
- Interaction with commercial, marketing, and R&D where needed