Job Overview:
Assist with the overall Clinical Safety and/or PSS operations associated with products including the adverse events process which may include safety data collected from clinical trials and/or post marketing setting (i.e., unsolicited reports). Manage and process expendable 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 safe 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:
- Process the adverse event reports from any source as per client/sponsor agreed plans.
Manage the receipt and processing of all adverse event reports reported either spontaneously from any source or 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 and code adverse events accurately using MedDRA, if applicable to Determine lists against appropriate label (for Marketed products, if applicable).
- Identifies clinically significant information missing from initial reports and generate queries for its collection, consulting the medical staff if needed.
- Ensure case receives appropriate medical review.
- Ensure all cases that require expediting reporting to worldwide regulatory agencies or other recipients are prioritized for processing and submission within the regulatory and/or study specific applicable timelines.
- Submission of expedited SAE reports to clients, Regulatory Authorities, Ethics Committees, investigators, 3rd party vendors, Partners and Fortrea project personnel, if required and as agreed with client during study set-up, within study specified timelines.
- Perform processing of Expedited Safety Reports (ESRs), Periodic Safety Reports (PSRs) and submission, including but not limited to- o Maintenance of tracking systems.
- Set-up and maintenance of project files and central files for documentation.
- Assist with the reporting of ESRs and PSRs to clients, Regulatory Authorities, Ethics Committees, investigators, and Fortrea project personnel, as required, within study specified timelines.
- Support with quality review or peer review of the processed reports.
- Assist and/or complete the database reconciliation and the associated activities, as applicable.
- Maintain study/project level documentation as per the agreed requirements, as applicable.
- Support with training of PSS staff and mentor the team as needed.
- Support with input required for monthly status reports, assist in the generation and maintenance of the PSS metrics (if needed).
- Maintain a comprehensive understanding of Standard Operating Procedures (SOPs), Work Instructions (WI), guidance/ procedural documents and directives associated with safety management, reporting, and pharmacovigilance.
- Assist in the preparation for client meetings and liaise with client contacts, where appropriate.
- Assist in Quality issues management and support audit and inspection preparation, as needed.
- Ensure compliance of operations with governing regulatory requirements and applicable study/project plans and take responsibility for quality of data processed.
- Assist in the preparation of client meetings and liaise with clients where appropriate ¨ Any other duties as assigned by management.
- The above job duties are completed by the staff as applicable, depending on the role they are assigned to.
Qualifications (Minimum Required):
- Non-degree + 1 year of Safety experience or 3 years relevant experience.
- Associate degree + 1 year of Safety experience or 2 years relevant experience.
- BS/BA + 1 year of relevant experience.
- MS/MA + 1 year of relevant experience.
- PharmD + 1 year of relevant experience.
- For PharmD, a one-year residency of fellowship can be considered as relevant experience.
Degree preferred to be in one or more of the following disciplines:- Biological Sciences, Pharmacy, Nursing, Medical Sciences, Life Sciences, or related area.
Experience (Minimum Required):
- High degree of accuracy with attention to detail.
- Functions as a team player and offer peer support as needed.
- Good written and verbal communication skills.
- Ability to work independently with moderate supervision.
- Good keyboard skills with knowledge of MS Office and Windows application would be beneficial ¨ Mentoring skills preferred.
Preferred Qualifications Include:
- Office Environment or remote.
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