Assoc I PSS

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).

Responsible to provide all clients, both internal and external, with the appropriate quality of service in a safe and cost-effective manner.

Responsibilities

• 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.
• 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.
• 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.

Requirements

• 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.
• 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.

Preferred

• Good keyboard skills with knowledge of MS Office and Windows application would be beneficial ¨ Mentoring skills preferred.
• Office Environment or remote.

Learn more about our EEO & Accommodations request here .