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Role Summary: The job holder is responsible for implementing and maintaining the national pharmacovigilance system according to the current pharmacovigilance agreement between the local GE Healthcare office and the global GE Healthcare pharmacovigilance organization.
Essential Responsibilities: • Ensuring that the national pharmacovigilance is compliant with national laws • Establishing and maintaining a system which allows to detect, collect and process on a national level adverse events, reports on pregnancies, overdose, falcified medicines, drug administration errors, medication error, occupational exposure, off label use, misuse and abuse • Adequate and timely reporting of local adverse events to the CSU • Follow the instructions of global RA concerning PSUR submissions and renewals • Local literature screening • Maintaining a training system for pharmacovigilance related tasks (limited to staff members based in the territory (Belgium) • The job holder acts as primary contact point the agency • Assist in audits and inspections • Ensure that the Deputy is aware of all pending safety issues when he has to take over in cases of replacement • Maintaining an archiving system for pharmacovigilance and safety related information
Qualifications/Requirements: 1. A postgraduate degree in Clinical Medicine and licensed within their respective specialty. 2. Experience in any of radiology, nuclear medicine or cardiology would be an advantage. 3. Minimum of 2+ years of experience in a pharmacovigilance role in the pharmaceutical industry. 4. Demonstrated management skills within the Pharmacy Industry 5. Good commercial acumen and experience in a commercial environment. 6. Demonstrate excellent communication and presentation skills to a range of internal and external customers 7. Fluent in English (both written and oral) and any other language.
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