Are you passionate about contributing to the pharmaceutical and biotechnology sectors? Fortrea, a leading global contract research organization (CRO), is on the lookout for talented individuals to join their dynamic team as a Safety Writing Associate II in Mumbai. If you have a background in life sciences and are keen to work in a fast-paced, innovative environment, this might be the perfect opportunity for you.
About Fortrea
Fortrea is dedicated to transforming drug and device development across the globe. With years of clinical development experience and operations in approximately 100 countries, we offer a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Our commitment to scientific rigor makes us a trusted partner for pharmaceutical, biotechnology, and medical device customers worldwide.
Job Overview
As a Safety Writing Associate II, you will play a vital role in the preparation and review of aggregate safety, risk management, and signal detection reports. Your responsibilities will include assisting medical writers, preparing data summaries, literature abstracts, and participating in the review process to ensure high-quality document delivery to internal customers and clients.
Key Responsibilities
- Report Generation: Generate reports from databases and safety systems, ensure timely delivery, and maintain organization of data requests.
- Safety Reports Authoring: Author sections of various safety reports, including Annual Reports, Periodic Safety Update Reports, Risk Management Plans, and more.
- Data Analysis: Develop assigned report parts that may involve template text and analyzing safety data summaries.
- Signal Detection Activities: Collaborate with medical writers in signal detection, data cleaning, and preparation for signal review meetings.
- Ad Hoc Reporting: Prepare safety issue analysis reports and supporting documents for regulatory submissions.
- Literature Searches: Conduct thorough literature reviews and prepare summaries or abstracts for safety reports.
Qualifications
To be considered for the Safety Writing Associate II position, candidates should have:
- A minimum first degree in life sciences or equivalent experience.
- Excellent command of written and spoken English.
- Strong communication skills, familiarity with MS Office, and good organizational abilities.
- Understanding of regulatory requirements, good Pharmacovigilance practices, and ICH GCP guidelines.
Preferred Qualifications
- An advanced degree (e.g., PhD or Masters) is preferred.
- Two years of experience in medical writing or the pharmaceutical industry.
Work Environment
The position offers flexibility with both office and remote work options, ensuring a balanced work-life dynamic. At Fortrea, we encourage motivated problem-solvers and creative thinkers who are passionate about improving clinical trials and patient outcomes.
