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 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:
Assist in the processing of Expedited Safety Reports (ESRs), Periodic Safety Reports (PSRs) and submission, including 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.
- Ensure all incoming Adverse Event (AE)/ Serious Adverse Event (SAE) reports are appropriately logged into the departmental tracking application and forwarded to the centralized mailbox.
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).
- Generate queries for its 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.
- Maintenance of adverse event tracking systems
- Assist with peer/quality review of processed reports and support with trends and actions as needed.
- Assist in the reconciliation of databases, as applicable.
- Assist in the maintenance of files regarding adverse event reporting requirements in all countries.
- Work within the Quality Management System framework, including but not limited to Standard Operating Procedure (SOP), departmental Work Instructions (WIs) etc. as appropriate.
- Prepare and support coordination of safety study files for archiving at completion of projects.
- Arrange and schedule internal and/or external meetings/teleconferences.
- Train and mentor, the PSS Assistants or peers in their day-to-day activities.
- Build and maintain good PSS relationships across functional units.
- Ensure compliance of operations with governing regulatory requirements and applicable study/project specific plans.
- Assume responsibility for quality of data processed. Provide administrative support to PSS personnel.
- All other duties as needed or assigned.
Qualifications (Minimum Required):
- Non-Degree or 1-2 years of Safety experience* or relevant experience**
- Associate degree or 6 months to 1 year of Safety experience* or relevant experience**
- BS/BA with 0-6 months to 1 year of Safety experience* or relevant experience**
- MS/MA with 0-6 months of Safety experience* or relevant experience**
- PharmD with 0-6 months of Safety experience* or relevant experience**
- For PharmD, a one-year residency of fellowship can be considered as relevant experience. To be considered in lieu of 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.
- Speaking: English and local language.
- Writing/Reading: English and local language.
Experience (Minimum Required):
- Good Team player and offer peer support as needed.
- Ability to set priorities and handle multiple tasks.
- Attention to detail.
- Good written and verbal communication skills.
- Logical and spelling skills, preferably with an aptitude for handling and proof-reading numerical data.
- Good keyboard skills, preferably with knowledge of MS office and Windows would be beneficial.
- Ability to operate standard office equipment.
Physical Demands/Work Environment:
- Office Environment or remote.
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