Job Overview:
Responsible for assisting with 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 setting (i.e., unsolicited reports). Manage and process expeditable 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:
- Manage the receipt and processing of all adverse event reports reported either spontaneously from any source or solicited 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, Code adverse events accurately using MedDRA.
- Determine listedness against appropriate label (for Marketed products, if applicable).
- Identifies clinically significant information missing from the reports and ensures its collection; Prepare follow-up correspondence in consultation with the medical staff, as needed.
- Ensure case receives appropriate medical review.
- Ensure all cases that require expediting reporting to worldwide regulatory agencies and other required parties are processed swiftly and appropriately within required timelines.
- Reporting of endpoints to clients, regulatory authorities, ethics committees, investigators, 3rd party vendor, Partner and Fortrea project personnel, if required, within study specified timelines.
- Submission of expedited Serious Adverse Event (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.
- Assist or contribute to Database reconciliation in liaison with Data Management team or clients.
- Manage processing of Expedited Safety Reports (ESRs), Periodic Safety Reports (PSRs) and submission, includes but not limited to:
- Maintenance of adverse event 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.
- Perform quality review or peer review of processed reports and support the Line Management with trends and actions needed.
- Maintains a comprehensive understanding of Standard Operating Procedures (SOPs), Work Instructions (WI), guidance documents and directives associated with safety management, reporting and pharmacovigilance.
- Assist in the generation and maintenance of the PSS metrics.
- Support preparation for client meetings and liaise with clients where appropriate.
- Assist with the set-up of, and the provision of data to Safety Committees/DSMBs as applicable.
- Prepare and support coordination of safety study files for archiving at completion of projects.
- Support Root cause analysis and CAPA plan development for the identified quality issues, as needed.
- Support and/or participate in audits and inspections including the preparation, as needed.
- Demonstrate role-specific Core Competencies and company values on a consistent basis. Build and maintain good PSS relationships across functional units.
- All other duties as needed or assigned.
Qualifications (Minimum Required):
- Non-degree + 2 yrs. safety experience * or 3-4 yrs. relevant experience**
- Associate degree + 2 yrs. safety experience* or 2-3 yrs. relevant experience**
- BS/BA + 1 year of Safety experience* or 2 yrs. of relevant experience**
- MS/MA + 1 year of Safety experience* or 1-2 yrs. of relevant experience**
- PharmD + 1 year of Safety experience* or 1-2 yrs. 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.
- * Safety experience includes actual experience 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.
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
Experience (Minimum Required):
- High degree of accuracy with attention to detail.
- Functions as a team player.
- Good written and verbal communication skills.
- Good Presentation skills preferred.
- Ability to work independently with minimal supervision.
- Good keyboard skills with knowledge of MS Office and Windows application would be beneficial.
- Training and mentoring skills preferred.
Preferred Qualifications Include:
- Office Environment or remote.
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