Fortrea is a globally renowned contract research organization (CRO) with a legacy of scientific rigor and clinical development expertise. Operating in nearly 100 countries, Fortrea provides pharmaceutical, biotechnology, and medical device clients with cutting-edge solutions across more than 20 therapeutic areas. The company is dedicated to transforming drug and device development, ensuring swift delivery of life-changing therapies to patients worldwide. Fortrea fosters an inclusive workplace, making it a standout employer in clinical research and development.
Responsibilities in the Job
As a Safety Writer at Fortrea, you will play a critical role in ensuring compliance and quality in regulatory and safety documentation. Your key responsibilities will include:
- Report Preparation and Review:
- Authoring and reviewing various safety reports, including IND Annual Reports, PSURs, DSURs, and Risk Management Plans.
- Preparing ad hoc reports and benefit-risk evaluations.
- Quality Oversight:
- Conducting quality reviews of safety reports prepared by junior or associate writers.
- Ensuring adherence to regulatory standards and guidelines.
- Scientific Analysis:
- Conducting literature searches and reviews for safety reporting.
- Drafting literature abstracts, summaries, and Company comments.
- Communication and Collaboration:
- Coordinating with internal and external stakeholders to ensure timely and accurate data inputs.
- Participating in discussions for label updates and regulatory documentation.
- Compliance and Best Practices:
- Promoting efficient, quality processes for timely deliverables.
- Adhering to regulatory and pharmacovigilance standards.
Qualifications
Fortrea seeks candidates with the following qualifications:
- A minimum of a bachelor’s degree in life sciences or equivalent. Advanced degrees (e.g., Master’s or Ph.D.) are preferred.
- At least three years of experience in the pharmaceutical industry, with two years in medical writing.
- Comprehensive understanding of regulatory requirements, good pharmacovigilance practices, and ICH-GCP guidelines.
Skills
The ideal candidate will possess:
- Excellent written and verbal communication skills in English.
- Proficiency in MS Office applications.
- Strong organizational and time-management abilities.
- Exceptional interpersonal skills for effective collaboration.
- Desirable scientific or clinical research experience.
