Signal Detection Senior Analyst
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 all the necessary data for review. Draft the meeting report in the Electronic Data Management System using the applicable template. Compile and distribute the report applicable stakeholders prior to the meeting. Host the meeting and document the review and any applicable action items in the report. Update the report and distribute it for review. Address the review comments and compile the draft for quality check. Finalize the report after addressing the QC comments and Route the final report to GSO for approval. Enter information from the meeting in the Safety Surveillance and Aggregate Reports (SSA) tracker.
Meetings: Liaise with PV Scientist to define the attendees and stakeholders for meeting. Schedule the meetings and send Request for Information to the shareholders. Compile the slide deck based on input from stakeholders. Prepare meeting minutes using the applicable template.
Perform the Signal management activities as per SOPs, Job Aids and guidelines as agreed during the meetings and/or weekly team meeting.
On -time escalation of any delayed inputs/ review comments/ endorsement as per process.
Archive the supporting documents used to, prepare the aggregate reports in the SharePoint or electronic repository as per the defined timelines
Provide responses to the query related to reports as per the requested timeline · Complete the training as per the assigned timeline
Work with the IT systems where required (Tableau, BEAMS and SharePoint).
Educational requirement: Medical Degree (MBBS or MD)
Work experience requirement: mandatory 2 to 3 years of experience in safety signal detection.
Prior experience with safety database systems (e.g., Argus, ARISg) safety signal detection tools or PV/Aggregate reporting experience is desirable.
Strong understanding of pharmacovigilance regulations, guidelines, and requirements (e.g., ICH, FDA, EMA).
Excellent analytical skills, attention to detail, and ability to critically evaluate safety data. Effective communication and interpersonal skills, with the ability to collaborate with internal and external stakeholders.
Prague
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