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Signal Detection Physician

Accenture · Prague, CZ

Overall Purpose of the Job Responsible for medical review and leading the Signal Management activities including weekly literature review, authoring of signa...

Job description

Overall Purpose of the Job Responsible for medical review and leading the Signal Management activities including weekly literature review, authoring of signal reports (Signal Management aid Review Team reports) and project management of Safety Surveillance team meeting within the agreed timeframes and accuracy, in compliance with business miles, standard operating procedures (SOP) and global regulatory requirements, all as documented in Quality documents as applicable. Responsibilities: - Safety assessment - Literature review: On a weekly basis, review abstracts and articles for safety signals and/or for possible inclusion in the aggregate reports and record assessments in appropriate trackers. Liaise with Global Safety Officer (GSO") Pharmacovigilance (PV) Scientist if a potential safety signal is identified upon review of the weekly alerts or in case of doubt. summary of articles of interest for GSO review with PV Scientist in copy in advance of the meetings. Complete the Literature Search Alert Tracker once GSO response received. - Meeting: Liaise with counterpart to identify the attendees and stakeholders for meeting. Schedule meetings and liaise with stakeholders and collate a...