Leading worldwide Contract Research Organization (CRO) Fortrea is renowned for its dedication to clinical development excellence and scientific rigor. Fortrea has partnered with pharmaceutical, biotechnology, and medical device businesses for over 20 years. With this knowledge, Fortrea offers complete clinical development, patient access, and technology solutions. With a workforce of over 19,000 individuals and operations in over 90 countries, Fortrea is committed to revolutionizing the drug and device development landscape and providing patients with life-changing medications globally.
Responsibilities of a Safety Writer at Fortrea
You will play a key role in upholding strict adherence to legal requirements and maintaining high levels of quality in safety paperwork as a Safety Writer at Fortrea. Your primary duties will consist of:
- Ensuring Regulatory Compliance: Adopt and encourage standardized, effective, and high-quality procedures to fulfill deadlines and deliverables in accordance with SOPs and regulations.
- Writing Safety Reports: For submission to international regulatory bodies, write and review a variety of safety reports, including as annual reports, periodic safety update reports, periodic adverse drug experience reports, and more.
- Conducting literature searches and taking part in signal detecting activities can help with the drafting of safety reports.
- Supplementary Records and Instruction: Write supplementary materials, including Standard Operating Procedures (SOPs), Safety Update Reports, and Risk Management Plans (RMPs). In addition, you can be in charge of leading team and peer training sessions.
- Collaborative Environment: Help the team establish a high standard of accountability and customer service.
Am I a Good Fit for This Job?
Take into account your suitability for the Safety Writer role at Fortrea by evaluating your possession of the following abilities and credentials:
- Regulatory Knowledge: Proficiency in meeting regulatory standards, specifically in regard to safety documentation for biotechnology, pharmaceutical, or medical device companies.
- Technical writing abilities: Skill in creating and evaluating intricate safety reports and associated materials.
- Analytical Proficiency: Excellent at searching the literature and evaluating safety data to back up regulatory filings.
- High attention to detail is necessary to guarantee the precision and caliber of safety documentation.
- Teamwork: The capacity to cooperate in a fast-moving, international setting.
- Training Skills: Being able to mentor colleagues or provide training to others can be a great advantage.
How to Apply
Fortrea welcomes you to apply for the Safety Writer post if you’re enthusiastic about having a global effect in the clinical research sector. Through their website or job advertising platform, you can apply directly. Make sure your cover letter and CV are tailored to the position and reflect Fortrea’s values.
