Job
Description
As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Conducting operations in ~100 countries, Fortrea is transforming drug and device development for partners and patients across the globe. **Role 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. - 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 a 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. - 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. **Key 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, listed assessment against appropriate label (for Marketed products, if applicable). - Manage submission of expedited SAE reports to clients, Regulatory Authorities, Ethics Committees, investigators, 3rd party vendors, Partner and Labcorp project personnel, if required and as agreed with the 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. - Prepare 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. - Maintain a strong understanding of Labcorp's safety database conventions or client-specific database conventions, as appropriate. - Participate in signal detection, trend and pattern recognition activities, as appropriate. - Begin to participate and demonstrate leadership on projects which enhance team and/or division performance. This includes acting as a lead contact for projects including global projects ensuring communication and process harmonization. **Qualifications Required:** - 7+ years of relevant work experience in Pharmacovigilance - Experience in Clinical Trial case processing is mandatory - 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.,
