Job Overview:

Manage ‘Client’ or ‘Project’ specific 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) for specified projects. 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. 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. Provide all clients, both internal and external, with the appropriate quality of service in a safe and cost-effective manner. The role will be expected to comply with the legal requirements of the Health and Safety at Work Act 1974, the COSHH regulations 1989 and EC (European Commission) Directives 1992/3 as documented in the Company’s Health and Safety Manual.

Summary of Responsibilities:

• Provide leadership and management of global or regional projects ensuring that communications and processes are harmonized for assigned projects.
• Monitor and manage the workflow for assigned projects to ensure all deadlines are met and compliant safety reporting in accordance with international reporting regulations, Standard Operating Procedures (SOPs) and safety processing guidelines set forth by departmental management team.
• Responsible for making decisions regarding adverse event reporting within the guidelines of each assigned project.
• Work closely with the clinical operations and project management groups to ensure all PSS activities are performed according to the regulatory and contractual requirements.
Provide oversight of the receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial for assigned projects. This includes, but is not limited to:
• 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 expectedness/listedness against appropriate label.
• Identifies clinically significant information missing from initial reports and ensures its collection.
• Ensure case receives appropriate medical review.
• Prepare follow-up correspondence consulting with the medical staff accordingly.
• Ensure all cases that require expediting reporting to worldwide regulatory agencies are processed swiftly and appropriately within required timelines.
• Reporting of endpoints to clients, regulatory authorities, ethics committees, investigators and Fortrea project personnel, if required, within study specified timelines.
Provide oversight of the management and processing of expedited safety reports (ESRs) for assigned projects. This includes, but is not limited to:
• Review and update adverse event databases and tracking systems.
• Review of adverse events for completeness, accuracy, and appropriateness for expedited reporting.
• Review of patient narratives.
• Review the coding of adverse events.
• Review of reporting of ESRs and endpoints to clients, regulatory authorities, ethics committees, investigators and Fortrea project personnel, if required, within study specified timelines.
• Execute and/or ensure routine quality review of adverse event reports and aggregate reports ensuring that case processing and data quality meet global regulatory compliance standards for assigned projects.
• Complete triage, distribution checklist and quality review of all ESRs for assigned projects.
• Provide oversight and management of EudraVigilance activities for assigned projects.
• Maintain a strong understanding of Fortrea’s safety database conventions or client specific database conventions and system functionality.
• Provide oversight and/or perform signal detection and trend and pattern recognition activities, as required for assigned projects.
• Preparation of Safety Management Plans (SMPs), Reconciliation Plans, and other safety specific plans ensuring optimal efficiency.
• Provide oversight and/or preparation of timely pharmacovigilance reports for products and safety issues, including but not limited to Individual Case Summary Reports (ICSR) of Serious Adverse Events (SAEs) and aggregate reporting.
• Monitor and manage project deliverables regarding contract assumptions; identifying out of scope work or potential to run over budget.
• Contribute to the generation and review of Time and Cost Estimates for PSS business.
• Generation of monthly status and other project-specific reports ensuring the quality and accuracy of metrics and data provided.
• Attend client meetings and liaise with clients where appropriate.
• Consistently contributes to solving technical and/or operational problems of program/project members.
• Consistently proposes and executes innovative solutions which influence program/project direction.
• Provide PSS project training for assigned projects for PSS, Clinical Operations/Project Management, Client, and Investigators as required.
• Prepare and participate in audits, either by the client or a regulatory agency.
• Maintenance of files regarding adverse event reporting requirements in all countries.
• Manage the review of cumulative safety data for submission to DSMBs, regulatory authorities or clients.
• Manage the set-up of, and the provision of data to Safety Committees / Drug Safety Monitoring Boards.
• Manage the co-ordination of endpoint committees as needed.
• Work with Data Management or client on reconciliation of safety databases, if appropriate.
• Contributes to the development and/or review of Clinical Trial Protocols, Case Report Forms and Adverse Event Reporting forms.
Prepare and deliver safety presentations:
• Serious Adverse Event reporting at investigator meetings.
• Client capabilities meetings, as appropriate.
• “Department Overview” to internal clients.
• Maintains a comprehensive understanding of PSS SOPs, Work Instructions (WI), guidance documents and directives associated with safety management, reporting and pharmacovigilance.
• Possess knowledge of other CDS procedural documents, e.g., SOPs, WIs, etc. impacting safety.
• Contribute to the development of departmental Work Instructions (WI) and Standard Operating Procedures (SOPs), as appropriate.
• Provide support and training in all aspects of case-handling, adverse event reporting and other tasks for team members of assigned projects.
• Acts as a mentor to less experienced colleagues.
• Responsible for cascading relevant information from internal and external meetings to PSS management and appropriate colleagues.
• May supervise workloads and individual performance of more junior team members.
• Build and maintain good drug safety relationships across functional units.
• Demonstrate role specific Competencies on consistent basis.
• Demonstrate company Values on a consistent basis.
• Financial authority as it relates to projects.
• All other duties as needed or assigned.

Qualifications (Minimum Required):

• Non-degree + 6-7 yrs. Safety experience*
• Associate degree + 5-6 yrs. Safety experience*
• Associate degree RN + 5-6 yrs. Safety experience*
• BS/BA + 4-5 yrs. Safety experience*
• MS/MA + 3-4 yrs. relevant experience** or 2-3 yrs. Safety experience*
• PharmD + 2-3 yrs. relevant experience** or 1-2 yrs. Safety experience*
• For PharmD, a one-year residency of fellowship can be considered relevant experience.
• Degree preferred to be in one or more of the following disciplines: Biological Sciences, Pharmacy, Nursing, Life Sciences, and Chemistry.
• * 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, partly in related areas such as Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical Data Monitor, Regulatory Affairs, or Quality Assurance.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

Experience (Minimum Required):

• Compliance with client and global regulatory requirements.
• Good knowledge of the relevant worldwide pharmacovigilance regulations and guidelines.
• Good knowledge of Good Clinical Practice (GCP) related to clinical safety documentation.
• Good knowledge of ICH guidelines.
• Good knowledge of medical and drug terminology.
• Work collaboratively with PSS Management’s team.
• Good verbal, written and presentation skills.
• Good communication.
• Leadership capabilities.
• Anticipate/identify problems and takes appropriate action to correct.
• Knowledge of aggregate reporting.
• Awareness of the regulatory environment regarding Risk Management and Pharmacovigilance.
• Good keyboard skills, preferably with knowledge of MS office and Windows would be beneficial.
• Financially intuitive.

Preferred Qualifications Include:

• EudraVigilance Certification preferred.
• Knowledge of Medical Device Reporting desirable.

Physical Demands/Work Environment:

• Office environment.
• Travel required 10-15% of the time including overnight stays as necessary, consistent with project needs and office location.

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