Lead Safety Science Specialist

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 Fortreaproject personnel, if required 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 safetyspecific 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.

Skills Required

Pharmacovigilance, Clinical Safety, Regulatory Reporting