Job Overview:
Responsible for assisting with overall Clinical Safety and/or PSS operations associated with products including the entire adverse events process, which may include safety data collected from clinical trials and/or post marketing setting (i.e., unsolicited reports). Manage and process expeditable adverse events to the required standard and submit them to the client and the regulatory agencies (if required) within the agreed/stated timelines. Responsible for providing this service to clients either as a support function to the client project groups or as stand- alone business. Responsible to provide all clients, both internal and external, with the appropriate quality of service in a secure and cost-effective manner. He/she will be expected to comply with the legal requirements of the Health and Safety at Work Act 1974, the COSHH regulations 1989 and the EC (European Commission) Directives 1992/3 as documented in the Company’s Health and Safety Manual.
Summary of Responsibilities:
Manage the receipt and processing of all adverse event reports reported either spontaneously from any source or solicited from a clinical trial. This includes, but is not limited to:
Data entry of safety data onto adverse event database(s) and tracking systems.
Review of adverse events for completeness, accuracy and appropriateness for expedited reporting.
Write patient narratives, Code adverse events accurately using MedDRA.
Determine listedness against appropriate label (for Marketed products, if applicable).
Identifies clinically significant information missing from the reports and ensures its collection; Prepare follow-up correspondence in consultation with the medical staff, as needed.
Ensure case receives appropriate medical review.
Ensure all cases that require expediting reporting to worldwide regulatory agencies and other required parties are processed swiftly and appropriately within required timelines.
Reporting of endpoints to clients, regulatory authorities, ethics