Assoc I PSS

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. The role requires compliance with 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, including 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, as applicable, to determine lists against appropriate label for marketed products if applicable.
• Identify clinically significant information missing from initial reports and generate queries for its collection, consulting medical staff as needed.
• Ensure case receives appropriate medical review and that expedited reporting to worldwide regulatory agencies or other recipients is prioritized for processing within regulatory and study timelines.
• Submit expedited SAE reports to clients, Regulatory Authorities, Ethics Committees, investigators, 3rd party vendors, Partners and Fortrea project personnel, if required and as agreed with the client during study set-up, within study timelines.
• Process Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs) and maintain related submissions and tracking systems.
• Set up and maintain project files and central files for documentation.
• Assist with reporting ESRs and PSRs to clients, Regulatory Authorities, Ethics Committees, investigators, and Fortrea project personnel, as required within study timelines.
• Support quality review or peer review of processed reports.
• Assist with database reconciliation and related activities, as applicable.
• Maintain study/project level documentation per agreed requirements.
• Support training of PSS staff and mentor the team as needed.
• Support input required for monthly status reports and assist in the generation and maintenance of PSS metrics (if needed).
• Maintain understanding of SOPs, WI, guidance documents and directives related to safety management, reporting and pharmacovigilance.
• Assist in 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 regulatory requirements and applicable study/project plans; take responsibility for data quality.
• Other duties as assigned by management and as applicable to assigned role.

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 or fellowship can be considered as relevant experience.

Degree preferred

• 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 offers 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; mentoring skills preferred.

Preferred Qualifications Include

• Office environment or remote work.

Learn more about our EEO & Accommodations request here.

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