- 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 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
- Collaborate with the Clinical Safety group to be up to date with all the safety information required to complete a robust medical review of Safety Reports and assessment of company causality.
- Working in collaboration with Sponsor when needed to ensure a timely response to relevant safety queries from other company stakeholders and indirectly from regulatory authorities, particularly those associated with MDV reportable incidents/events.
- Assuring and maintaining compliance with regulatory and local/global SOP timelines using proactive workflow management.
Required Experience and/Competencies Required:
- Knowledge of medical device risk classification
- Practical experience within clinical or medical device safety setting
- Good knowledge of and interest in MDV practices
- Ability to evaluate and interpret scientific data
- Good knowledge of US and EU medical device vigilance regulatory requirements (e.g. MDR)
- Excellent written and verbal communication skills and ability to present and critically
- discuss MDV data in both internal and external discussions
