General Electric Medical Director, Global Pharmacovigilance in Marlborough, Massachusetts
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The Medical Director, Global Pharmacovigilance provides medical review comments on adverse event reports for GE Healthcare Core Imaging injectable contrast media and radiopharmaceutical products. This is a key role in the safety surveillance and risk management of our drug and device product. This position reports to the Sr Medical Director, Global Pharmacovigilance and QPPV.
This position has primary accountability for medical soundness and accuracy of individual case safety reports (ICSRs) for Core Imaging development and marketed drug products.
Specific Responsibilities (but are not limited to)
• Clinical trial SAE assessment and reporting responsibility
• Provides medical review comments in the global safety database Argus (current version 8.0.x) on adverse event reports from interventional clinical trials and non-interventional studies. Performs and approves analysis of similar events (AOSE) as required by applicable legislation.
• Provides or reviews and/or approves expectedness lists for development and marketed products in clinical studies.
• Advises or reviews MedDRA coding of events and diseases. Advises the PV Case processing team on study specific data elements.
Postmarketing pharmacovigilance responsibility
• Provides medical review comments in the global safety database Argus (current version 8.0.x) on serious adverse event reports from postmarketing reporting, including reports from scientific literature. Works together with the PV Case processing team on improvement.
• MD,DO, MBBS or relevant clinical degree and 7 years relevant work experience
• Minimum 3 years (a must) of medical review of ICSRs of clinical trial and postmarketing serious adverse events within pharmaceutical and/or biotechnology industry or service provider
• Experience in case narrative preparation and analysis of similar events AOSE
• Experience with MedDRA
• Strong working knowledge of applicable regulations and ICH guidelines
• Working experience with safety database Argus 8.0.x
• Knowledge of other languages than English
• Experience from clinical practice, experience in conduct of clinical trials
• Experience in other pharmacovigilance tasks (advantage). Examples are safety signal evaluation, review of scientific literature, preparation of risk management plans, preparation of periodic reports (PSUR, DSUR, or PADER)
• Ability to work constructively with individuals on all levels of seniority
• High integrity, sense of urgency, ability to recognize time sensitivity, willingness to work in a matrix environment, willingness to work independently and with team members in different locations and time zones
• Available for domestic and international travel
Locations: United States; Massachusetts; Marlborough
GE will only employ those who are legally authorized to work in the United States for this opening.