Assist with the 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 settings (ie, unsolicited reports)
Manage and process expendable adverse events to the required standard and submit them to the client and/or 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 safe and cost effective manner
The role will be expected to comply with the legal requirements of the Health & Safety at Work Act 1974, the COSHH regulations 1989 and the EC (European Commission) Directives 1992/3 as documented in the Company s Health & Safety Manual