PV/Drug Safety

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.

Assist in or complete per the Safety Management Plan (SMP) the processing of all adverse event reports from any source. Assist in producing queries of safety data for clients as appropriate. Assist in the generation and maintenance of the PSS metrics. Assist Data Management or clients on reconciliation of safety databases. Provide input for monthly status reports. Maintains a comprehensive understanding of Standard Operating Procedures (SOPs), Work Instructions (WI), guidance documents and directives associated with safety management, reporting and pharmacovigilance. Possess knowledge of other procedural documents, e.g., SOPs, and how they impact safety. Build and maintain good PSS relationships across functional units. Demonstrate role-specific Core Competencies on a consistent basis. Demonstrate company Values on a consistent basis. Assist in the preparation of client meetings and liaise with clients where appropriate. Assist with the set-up of, and the provision of data to, Safety Committees/DSMBs. Any other duties as assigned by management.

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.

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