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 expendable adverse events to the required standard and submit them to the client and the regulatory agencies (if required) within the agreed/stated timelines. The post holder is 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 including safety database entry, AE review, write patient narratives with coding, follow-up of missing information, lists assessment against appropriate label (For Marketed products, if applicable).
- Submission of expedited Serious Adverse Event (SAE) reports to clients, Regulatory Authorities, Ethics Committees, investigators, third party vendors, Partners and Fortrea project personnel, if required and as agreed with client during study set-up, within study specified timelines.
- 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.
- Prepares timely pharmacovigilance reports for products and safety issues, including Individual Case Summary Reports (ICSRs) of Serious Adverse Events (SAEs), Annual IND reports, European Annual Safety Reports (ASRs), Development Safety Update Report (DSUR), Periodic Reports (PRs) line listings, and aggregate reports.
- Perform peer/independent QC of Safety reports as needed.
- Work with Data Management or client on reconciliation of safety databases, if appropriate.
- Maintain a strong understanding of Fortrea’ s safety database conventions or client-specific database conventions, as appropriate.
- Maintains a comprehensive understanding of Fortrea PSS Standard Operating Procedures (SOPs), Work Instructions (WI), guidance documents and directives associated with safety management, reporting, and pharmacovigilance.
- Assist in signal detection, trend, and pattern recognition activities, as appropriate ¨ Monitor workflow for assigned studies/programs to ensure all the timelines are met.
- Assist in the development of departmental Work Instructions (WI) and Standard Operating Procedures (SOPs), as appropriate.
- Participate in the generation of monthly status and other project-specific reports ensuring the quality and accuracy of metrics/data provided.
- Support/train less experienced safety staff in all aspects of case-handling, adverse event reporting and other work, as needed.
- Begin to prepare Safety Management Plans (SMPs), Reconciliation Plans and other safety- specific plans under supervision.
- Responsible for making decisions regarding adverse event reporting within the guidelines of each specific project.
- Actively participates in project team and client meetings and liaise with clients, where appropriate.
- Assist with proactive quality issue resolution and implementation of actions, as needed.
- Support audit or inspection preparations.
- Assist in the review of cumulative safety data for submission to Drug Safety Monitoring Boards (DSMBs), regulatory authorities or clients.
- Assist with the set-up of, and the provision of data to Safety Committees/DSMBs ¨ Build and maintain good PSS relationships across functional units.
- Demonstrate role-specific Competencies and company values on a consistent basis.
- Assist in the co-ordination of endpoint committees, as required.
- Any other duties as assigned by management.
Qualifications (Minimum Required):
- Non-degree + 2-3 years of Safety experience or 5 years of relevant experience.
- Associate degree + 2-3 years of Safety experience or 4 years of relevant experience.
- BS/BA + 2 years of safety experience or 3-4 years of relevant experience.
- MS/MA + 2 years of safety experience or 2-3 years of relevant experience.
- PharmD + 2 years of safety experience or 2-3 years relevant experience.
- For PharmD, a one-year residency of fellowship can be considered as relevant experience.
Experience (Minimum Required):
- Good verbal and written communication skills and good presentation skills.
- Ability to interact and influence with line and middle management, staff, and external contacts on a functional and tactical level.
- High degree of accuracy with attention to detail.
- Functions as a team player.
- Ability to present and share useful business information across departments and functions.
- Ability to anticipate and identify problems and take appropriate action to correct them.
- Knowledge of medical and drug terminology.
- Knowledge of Good Clinical Practice (GCP) related to clinical safety documentation.
- Knowledge of ICH Guidelines.
- Knowledge of Medical Device reporting desirable.
- Knowledge of worldwide regulatory requirements and reporting of adverse event for both marketed and investigational products.
- Good knowledge and understanding of industry and R and D processes and objectives.
- Ability to work independently with minimal supervision.
- Good keyboard skills, preferably with knowledge of MS office and Windows would be beneficial.
Preferred Qualifications Include:
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Degree preferred to be in one or more of the following disciplines:
- Biological Sciences, Pharmacy, Nursing, Medical Sciences, Life Sciences, or related area.
Physical Demands/Work Environment:
- Office environment.
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