Fortrea is a globally recognized contract research organization (CRO) renowned for its scientific rigor and decades of clinical development expertise. Specializing in clinical development, patient access, and technology solutions, Fortrea operates in over 100 countries, serving pharmaceutical, biotechnology, and medical device clients across more than 20 therapeutic areas. Committed to transforming drug and device development, Fortrea strives to bring life-changing therapies to patients worldwide.
Job Responsibilities
As a Safety Writing Associate II, your role will involve:
Key Responsibilities
- Preparation and Review of Reports: Develop and review sections of aggregate safety, risk management, and signal detection reports.
- Data Management: Generate outputs/reports from safety databases, manage data requests, and conduct regulatory website searches.
- Authoring Reports: Write comprehensive safety reports for global regulatory submissions, including Annual Reports, Periodic Safety Update Reports, Risk Management Plans, and more.
- Signal Detection Activities: Support medical writers by cleaning and reviewing data, creating materials for signal review meetings, and contributing to signal reports.
- Ad Hoc Reporting: Prepare safety issue analysis reports and other supporting documents for label updates.
- Literature Searches: Conduct searches, review outputs, and summarize selected articles relevant to safety reports.
- Quality Assurance: Ensure compliance with regulatory requirements and promote efficient processes.
- Client Interaction: Foster strong relationships with both internal and external clients, ensuring timely and high-quality service delivery.
Qualifications
Minimum Requirements
- A first degree in life sciences or an equivalent qualification.
- Excellent command of written and spoken English.
- Proficiency in MS Office.
- Good organizational and time management skills.
- Strong interpersonal abilities.
- Basic understanding of regulatory requirements, good pharmacovigilance practices, and ICH GCP guidelines.
Preferred Qualifications
- Advanced degree (e.g., PhD or Master’s) in life sciences.
- At least two years of experience in medical writing or the pharmaceutical industry.
Skills
- Exceptional written and verbal communication.
- Proficient in data summarization and analysis.
- Knowledge of regulatory compliance and good pharmacovigilance practices.
- Ability to work collaboratively in a team environment.
- Strong attention to detail and ability to handle multiple tasks efficiently.
