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. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

Specialist II - Patient Safety Solutions, Bulgaria – Remote

As a Specialist II in our Patient Safety Solutions team, you will assist with the overall Clinical Safety and/or Patient Safety Service operations, with particular focus on the independent QC of cases, as well as quality issue resolution and implementation of process improvement initiatives/activities. You will have the opportunity to work with multiple Sponsors in an experienced team.

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. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe. 

Did you know? 

Labcorp's Clinical Development and Commercialization Services business is now Fortrea in connection with its planned spin-off from Labcorp, which is expected in mid-2023. Fortrea’s spin-off from Labcorp is subject to satisfaction of certain customary conditions. This spin-off will position both organizations for accelerated growth and allow each to focus resources on distinct strategic priorities, customer and employee needs and value creation opportunities. As a provider of phase I-IV clinical trial management, regulatory guidance, patient access solutions and market access consulting, Fortrea will partner with both emerging and large pharmaceutical, biotechnology, device and diagnostic companies to drive healthcare innovation and improve the lives of patients worldwide.

Fortrea is looking for problem-solvers and creative thinkers who are passionate about breaking down barriers faced by sponsors of clinical trials, and who are committed to helping transform the development process to get promising life-changing ideas and therapies to patients faster. Join us as we cultivate a workspace where all employees have the opportunity to grow and make impacts on a global scale. For more information and questions related to Fortrea, please visit www.fortrea.com.

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:

• Entry of safety data onto adverse event database(s) and tracking systems
• Provide independent QC of AE reports for other members of the group
• Review of adverse events for completeness, accuracy and appropriateness for expedited reporting
• Write patient narratives
• Code adverse events accurately using MedDRA
• Identifies clinically significant information missing from initial reports and ensures its collection
• Ensure case receives appropriate medical review
• Prepare follow-up correspondence consulting 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 Labcorp project personnel, if required, within study specified timelines

May execute routine quality review of AE reports and aggregate reports for other members of the group ensuring that case processing and data quality meet global regulatory compliance needs including audit support.

Maintain a strong understanding of Labcorp safety database conventions or client-specific database conventions, as appropriate.

Participate in signal detection, trend and pattern recognition activities, as appropriate.

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.

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.

Work with Data Management or client on reconciliation of safety databases, if appropriate.

Monitor workflow for assigned studies/programs to ensure all deadlines are met.

Education

• University/college degree life science preferred one or more of the following disciplines: Biological Sciences, Pharmacy, Nursing, Life Sciences, and Chemistry or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution.

Experience

• Safety experience including actual experience processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions.

#LI REMOTE

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.

Fortrea is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

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