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:
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.
- Determine listedness against appropriate label (for Marketed products, if applicable).
- Identifies clinically significant information missing from the reports and ensures its collection and follow-up.
- 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 vendors, Partners 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.
- Perform Database reconciliation with Data Management team or sponsor/client as needed.
Perform processing and/or review and submission of Expedited Safety Reports (ESRs), Periodic Safety Reports (PSRs), 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.
- Maintain a strong understanding of Fortrea’s safety database conventions or client specific database conventions, as appropriate.
- Perform quality review or peer review of processed reports and support the Line Management with trends and actions needed.
- Begin participating in signal detection and trend and pattern recognition activities, as appropriate.
- Assist in the preparation of listings for Annual IND reports, Periodic Reports (PRs) like Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs) etc.
- Begin participating in the generation of monthly status and other project-specific reports ensuring the quality and accuracy of metrics and data provided.
- Support/train/mentor less experienced safety staff in all aspects of case-handling, adverse event reporting.
- Maintain a comprehensive understanding of Standard Operating Procedures (SOPs), Work Instructions (WI), guidance documents and directives associated with safety management, reporting and pharmacovigilance.
- Assist with review and update of Safety Management Plans (SMPs), Reconciliation Plans, and other safety- specific plans ensuring optimal efficiency.
- Participate in Fortrea project team and client meetings, as appropriate.
- Prepare and support coordination of safety study files for archiving at completion of projects.
- Contribute to root cause analysis, including the CAPA plan development and implementation.
- Support Audits and/or inspections preparation.
- Assist in review of cumulative safety data for submission to Drug Safety Monitoring Boards (DSMBs), regulatory authorities or clients, if applicable and coordination of end point committees.
- All other duties as needed or assigned.
Qualifications (Minimum Required):
- Non-degree + 2 years of Safety experience * or 4-5 years of relevant experience**
- Associate degree + 2 years of Safety experience * or 3-4 years of relevant experience**
- BS/BA + 1-2 years of Safety experience * or 2-3 years of relevant experience**
- MS/MA + 1-2 years of Safety experience * or 2 years of relevant experience**
- PharmD + 1-2 years of Safety experience * or 2 years 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 Communication and presentation skills.
- Good written and verbal communication skills.
- Knowledge of medical and drug terminology desirable.
- Familiarity of Good Clinical Practice (GCP) related to clinical safety documentation.
- Familiarity with ICH Guidelines.
- Familiarity of worldwide regulatory requirements and reporting of adverse event for both marketed and investigational products.
- Ability to work independently with minimal supervision.
- Good keyboard skills, preferably with knowledge of MS office and Windows.
- * 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.
Physical Demands/Work Environment:
- Office Environment.
- Available for travel 5% of the time including overnight stays as necessary consistent with project needs and office location.
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