Fortrea, a global leader in clinical research, offers comprehensive services in drug and device development, patient access, and technology solutions. With operations spanning over 100 countries, Fortrea is renowned for its innovative and scientific rigor, addressing challenges across more than 20 therapeutic areas. Joining Fortrea means contributing to the advancement of groundbreaking therapies that transform lives.
Responsibilities in the Job
As a Safety Science Analyst, you will play a pivotal role in the clinical safety and post-marketing operations for various products. Key responsibilities include:
- Managing adverse events and safety data from clinical trials and unsolicited reports.
- Data entry of safety information into tracking systems and ensuring accurate documentation.
- Writing detailed patient narratives and coding adverse events using MedDRA.
- Conducting listedness assessments and generating queries to address data discrepancies.
- Submitting expedited Serious Adverse Event (SAE) reports to clients, regulatory authorities, ethics committees, and other stakeholders.
- Assisting with the reconciliation of databases and maintaining compliance with quality management frameworks such as SOPs and departmental work instructions.
- Supporting the preparation and submission of periodic and expedited safety reports to global regulatory agencies within specified timelines.
- Building effective cross-functional relationships to ensure seamless operations.
Qualifications
To excel as a Safety Science Analyst at Fortrea, candidates should meet the following requirements:
- Educational Background:
- Non-degree with 6 months to 1 year of relevant safety experience.*
- Associate Degree with up to 6 months of relevant safety experience.*
- Bachelor’s, Master’s, or PharmD degree in Biological Sciences, Pharmacy, Nursing, Medical Sciences, Life Sciences, or a related field.
- Relevant Experience:
- Experience in pharmaceutical, biotechnology, or CRO industries in areas such as Medical Affairs, Clinical Data Management, Monitoring, Regulatory Affairs, or Quality Assurance.
- Familiarity with processing adverse event reports, generating narratives, managing safety databases, and regulatory submissions.
Skills
- Exceptional attention to detail and accuracy.
- Strong written and verbal communication skills.
- Proficiency in MS Office and Windows applications.
- Team-oriented mindset with excellent interpersonal skills.
- Ability to manage and proofread numerical data.
- Familiarity with standard office equipment.