Perform safety activities for assigned R&D projects or ophthalmic products, including identification and comprehensive assessment of safety signals from all sources (clinical through post-approval lifecycle management and externally).
Perform single case medical review in the safety database or line listings. Medical review will be performed by clinically/medically qualified associates.
Monitor the clinical safety of assigned products/projects, including literature review, adverse events, patient impact from technical complaints, and signal detection.
Provide safety input into clinical and regulatory deliverables, including Investigator’s Brochures, study protocols, reports, and clinical submission documents, as needed.
Identify safety signals based on the review of solicited or unsolicited single cases. Performs signal triage activities, evaluation, and presentation to management boards including preparatory activities.
Author or provide safety input to the product labeling and related documents.
Contribute to the safety profiling and risk management documents.
Provide guidance for coding, causality assessment, and determination of anticipated vs. unanticipated adverse event reports.
Provide relevant safety input and collaborates productively with colleagues from Global Medical Safety and business franchise functions.
Provide expert medical/scientific input into responses to inquiries from health authorities, healthcare professionals, or local affiliates on safety issues. Prepares safety data for health authority review boards.
Source: Job Diva – Job Listing