Job Overview:
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 (i.e., unsolicited reports). Manage and process expeditable 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 costeffective manner. The role 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:
Perform case intake and triage of the incoming safety information or reports from various sources either spontaneously or from a clinical trial.
Assist with processing of the adverse events, including but not limited to:
Data entry of safety data onto adverse event tracking systems.
Write patient narratives and code adverse events accurately using MedDRA (for Marketed products, if applicable).
Assist in the listedness assessment against appropriate label (for Marketed products, if applicable).
Assist in generation of queries and collection of missing or discrepant information in consultation with medical staff, if needed.
Submission of expedited SAE reports to clients, regulatory authorities, ethics committees, investigators, 3rd party vendors, Partners and Fortrea project personnel, as required within the agreed timelines.
Assist with processing and submission of expedited and periodic reports to worldwide regulatory agencies or other recipients (Clients, Regulatory Authorities, Ethics Committees, investigators and Fortrea project personnel etc.), and prioritize the reports for processing and submission within the regulatory and/or study specific applicable timelines.
Assist in the reconciliation of databases, as applicable.
Work within the Quality Management System framework, including but not limited to Standard Operating Procedure (SOP), departmental Work Instructions (WIs) etc. as appropriate.
Assist in the maintenance of supporting files/ documentation regarding adverse event reporting requirements in all countries, if applicable.
Support upload/archival of case/study/project documentation, as appropriate.
Build and maintain good PSS relationships across functional units.
Support compliance of operations with governing regulatory requirements.
All other duties as needed or assigned.
Qualifications (Minimum Required):
Non-Degree or 6 months - 1 year of Safety experience* or relevant experience **
Associate Degree with 0-6 months of Safety experience* or relevant experience**
BS/BA with 0- 6 months of Safety experience* or relevant experience**
MS/MA with 0 yrs. of Safety experience* or relevant experience**
PharmD with 0 yrs. of Safety experience* or relevant experience**
Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
To be used in lieu of experience, Degree required to be in one or more of the following disciplines: Biological Sciences, Pharmacy, Nursing, Medical Sciences, Life Sciences, or related area *Safety experience includes actual experience of processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions.
** Relevant experience includes experience in the pharmaceutical, biotechnology, or CRO industry, working in related areas such as Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical Data Monitoring, Regulatory Affairs, or Quality Assurance.
Experience (Minimum Required):
Attention to detail.
Team player.
Solid written and verbal communication skills.
Accurate math and spelling skills preferably with an aptitude for handling and proof-reading numerical data.
Knowledge of MS office Windows applications beneficial.
Ability to operate standard office equipment.
Physical Demands/Work Environment:
Office Environment or remote.
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