About Fortrea:
Fortrea is a globally recognized contract research organization (CRO) with a dedication to scientific precision and decades of expertise in clinical development. We provide a wide range of clinical development, patient access, and technology solutions to pharmaceutical, biotechnology, and medical device clients across more than 20 therapeutic areas. With a workforce of over 19,000 professionals operating in more than 90 countries, Fortrea is at the forefront of transforming drug and device development for patients and partners worldwide.
Job Summary:
The successful candidate will be responsible for key tasks related to the planning, preparation, and quality review of safety reports and regulatory submissions. This includes gathering data, developing strategies, leading kick-off meetings, and conducting discussions for comment resolution. The role involves writing and reviewing a variety of safety reports for global regulatory submissions, such as Annual Reports, Periodic Safety Update Reports (PSURs), Periodic Adverse Drug Experience Reports (PADERs), Development Safety Update Reports (DSURs), Risk Management Plans (RMPs), and other key documents. The candidate will also collaborate closely with internal teams and external stakeholders to ensure compliance and quality.
Key Responsibilities:
Qualifications:
Why Fortrea?
At Fortrea, we seek motivated problem-solvers and creative thinkers who are passionate about overcoming challenges in clinical trials. We foster a collaborative environment that supports personal growth while making a meaningful global impact. Join us in revolutionizing drug development and delivering life-changing therapies to patients in need.
Equal Opportunity Employer:
Fortrea is an Equal Opportunity Employer committed to promoting diversity and inclusion in the workplace. We make employment decisions based on business needs and the qualifications of individuals. We do not tolerate discrimination or harassment based on race, religion, color, national origin, gender, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all qualified applicants to apply.
For more information on how we manage personal data, please review our Privacy Statement.
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