Fortrea, a leading global contract research organization (CRO), is renowned for its commitment to scientific rigor and extensive clinical development expertise. With operations in over 90 countries, Fortrea provides a comprehensive suite of clinical development, patient access, and technology solutions for the pharmaceutical, biotechnology, and medical device sectors. Known for its dedication to advancing therapeutic innovations, Fortrea partners with clients to accelerate the delivery of life-changing treatments to patients worldwide.
Responsibilities in the Job
As a Safety Science Coordinator II at Fortrea, you will play a critical role in the management and processing of adverse event reports, ensuring compliance with regulatory requirements. Your primary responsibilities will include:
- Adverse Event Processing: Manage the receipt, review, and data entry of adverse event reports from various sources into designated databases and tracking systems.
- Case Review: Assess adverse events for completeness, accuracy, and determine the necessity for expedited reporting.
- Patient Narratives and Coding: Write comprehensive patient narratives and accurately code adverse events using MedDRA.
- Medical Review and Reporting: Ensure cases receive proper medical review and prioritize cases for timely submission to regulatory agencies and other recipients.
- Submission of Reports: Handle the preparation and submission of Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs) to clients, regulatory authorities, and relevant committees.
- Documentation and Project Maintenance: Maintain project-level documentation, set up files, and track all reporting activities.
- Quality Assurance: Support peer review, quality checks, and participate in database reconciliation processes.
- Training and Mentoring: Assist in training new staff members and mentor team members as needed.
- Compliance and Audit Support: Prepare for client meetings, liaise with client contacts, and assist with audit and inspection readiness.
Qualifications
To excel as a Safety Science Coordinator II, you should meet the following qualifications:
- Educational Background: A degree in Biological Sciences, Pharmacy, Nursing, Medical Sciences, Life Sciences, or a related field is preferred.
- Experience: 2-3 years of relevant experience in a similar role, showcasing knowledge and application of safety management and pharmacovigilance.
- Skills in Case Management: Proficiency in managing case data, ensuring thorough documentation, and compliance with timelines for reporting.
Essential Skills
Fortrea is looking for individuals who possess a blend of technical expertise and soft skills, including:
- Attention to Detail: Accuracy in reviewing and processing case data.
- Technical Competence: Familiarity with MedDRA coding, safety databases, and tracking systems.
- Communication Skills: Strong written and verbal communication for preparing patient narratives and interacting with clients.
- Regulatory Knowledge: An understanding of global regulatory requirements and safety reporting practices.
- Problem-Solving Ability: Quick thinking and a proactive approach to handling unexpected challenges.
- Collaboration and Mentoring: Ability to work collaboratively and mentor junior staff as needed.
