Safety Writing Assistant Job at Fortrea in Mumbai – Apply Today
Fortrea, a leading global contract research organization (CRO), is looking for a passionate Safety Writing Assistant to join its team in Mumbai. If you have a background in life sciences and are looking to contribute to the pharmaceutical industry, this position offers an excellent opportunity. As part of a dynamic team, you will assist in safety writing activities, regulatory submissions, and more, helping shape the future of drug and device development worldwide.
About Fortrea:
As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers with a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Conducting operations in ~100 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
Job Overview
Location: Mumbai
Time Type: Full time
End Date: February 24, 2025
Job Requisition ID: 25364
Summary of Responsibilities for Safety Writing Assistant
- Perform allied activities such as the generation of outputs/reports from databases or safety systems.
- Author parts of various safety reports for global regulatory submissions.
- Develop assigned report parts and review and annotate line listings.
- Support medical writers in signal detection activities.
- Write sections of Common Technical Document Summaries, including Non-Clinical and Clinical Overviews.
- Conduct literature searches for authoring several types of reports.
Qualifications (Minimum Required) for Safety Writing Assistant
- Minimum of first degree in life sciences (or equivalent).
- At least 6 months or a year’s experience in the pharmaceutical industry.
- Excellent command of written and spoken English.
- Good organizational and time management ability.
- Good understanding of regulatory requirements, good Pharmacovigilance practices, and ICH GCP guidelines.
Preferred Qualifications of Safety Writing Assistant
- Advanced degree (e.g., PhD or Masters) preferred.
Physical Demands/Work Environment
Available for travel 5% of the time, including overnight stays as necessary, consistent with project needs and office location.
Keywords: Safety Writing Assistant, Fortrea, Mumbai, Job Posting
