Fortrea, a leading global contract research organization (CRO), is on the lookout for a Safety Writer to join its dynamic team in Pune, India. As a CRO with decades of experience in clinical development, Fortrea offers innovative solutions to pharmaceutical, biotechnology, and medical device companies. If you’re passionate about scientific rigor and making a global impact on drug and device development, this position may be the perfect opportunity for you.
About Fortrea
Fortrea is a renowned contract research organization that provides comprehensive clinical development, patient access, and technology solutions across more than 20 therapeutic areas. With a global workforce of over 19,000 professionals operating in over 90 countries, Fortrea is dedicated to transforming the way drugs and devices are developed, ensuring timely access to life-saving treatments for patients worldwide. Their commitment to scientific excellence and innovation has made them a trusted partner for pharmaceutical, biotechnology, and medical device companies across the globe.
Responsibilities of the Safety Writer Role
As a Safety Writer at Fortrea, your primary responsibilities will include:
- Authoring and Reviewing Safety Reports: Prepare and review various safety-related reports for global regulatory submissions, including Periodic Safety Update Reports (PSURs), Risk Management Plans (RMPs), and other safety documents as needed.
- Signal Detection: Conduct and review signal detection activities to identify potential risks associated with drugs or devices.
- Literature Searches: Perform literature searches to author reports and support regulatory submissions.
- Supporting Documents: Generate line listings, summary tabulations, and other supporting documents for safety-related reports.
- SOPs and Process Documentation: Author and review Standard Operating Procedures (SOPs), Work Instructions (WIs), and process documents.
- Training and Mentorship: Conduct training sessions for peers and team members to promote best practices and ensure quality in safety writing tasks.
- Regulatory Compliance: Ensure all deliverables meet regulatory requirements and Fortrea’s high-quality standards.
This role plays a crucial part in ensuring that all safety-related documentation is accurate, clear, and complies with regulatory standards for global submission.
Qualifications and Requirements
To be successful in the Safety Writer role at Fortrea, candidates should meet the following qualifications:
- A Bachelor’s or Master’s degree in Life Sciences, Pharmaceutical Sciences, or a related field.
- Proven experience in safety writing, pharmacovigilance, or related regulatory writing roles within the clinical research or pharmaceutical industry.
- Familiarity with global regulatory requirements, such as ICH guidelines, FDA regulations, and EMA standards.
- Strong writing skills with a keen attention to detail and the ability to communicate complex safety information clearly.
- Ability to manage multiple projects and meet deadlines in a fast-paced environment.
- Proficiency with safety reporting tools, literature databases, and MS Office applications.
Skills Required
The ideal candidate will possess the following skills:
- Excellent Communication Skills: Ability to write clear, concise, and well-structured safety reports.
- Analytical Thinking: Strong skills in data analysis and the ability to identify and assess potential safety risks.
- Team Collaboration: Comfortable working with cross-functional teams and contributing to group discussions.
- Attention to Detail: Ability to review documents thoroughly and ensure the accuracy of all information.
- Proficiency in Safety Reporting Tools: Familiarity with tools used for signal detection, report generation, and literature searches.
