Roles & Responsibilities:-
- Accountable for Medical Review sponsor assessments in the clinical database, including:
- Assess Device Deficiencies (DD) for potential to cause or contribute to an Adverse Event (AE) (Seriousness).
- Assess Causality for all Adverse Events (rationale may need to be provided to justify).
- Assess Seriousness and upgrade the case from Non-Serious to Serious if required.
- Complete Assessments within business timelines.
- Accountable for the medical review of relevant clinical, other solicited and spontaneous cases (including literature articles), medical assessment (including seriousness, labelling and causality along with the company causality statement as well as IMDRF Annex E and F codes) and overall cohesiveness of safety reports for a particular product or group of products on a national, regional, or global basis in line with regulatory and SOP requirements.
- Accountable for correct identification of potential serious public health threats and events requiring escalation for safety issues from safety reports.
- Accountable for the final clinically relevant narrative and accordingly review and edit the narrative to ensure it is a concise stand-alone clinically relevant story in chronological order for the specific product/event combination(s).
- Accountable for the final medical review of Safety Reports including performing tasks such as communication with the appropriate Clinical Safety Personnel and where appropriate with the Clinical Science Group ensuring that all necessary queries have been addressed.
- Accountable for confirming that the correct strategy has been taken for the analysis of similar incidents/events (e.g. selection of IMDRF codes for search basis) for medical devices.
- Responsible for generating, sending and tracking medically relevant queries.
- Developing and maintaining thorough knowledge of the appropriate disease biology areas & important safety concerns for marketed medical devices as well medical devices in development for which the Medical Reviewer (Device) is responsible and maintaining awareness of critical AEs/and other issues for assigned product(s).
