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Fortrea Hiring Safety Writer in Pharmacovigilance
Overview
Position Name: Safety Writer
Organization: Fortrea
Qualification: PharmD, PhD, MD, or equivalent preferred
Experience: 1 to 2 Years
Salary: Not disclosed
Location: Mumbai
About Us: Fortrea is a leading global contract research organization (CRO), renowned for its scientific rigor and decades of clinical development experience. Serving pharmaceutical, biotechnology, and medical device companies, Fortrea offers a broad range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. With a workforce of over 19,000 employees spanning more than 90 countries, Fortrea is committed to transforming drug and device development, bringing life-changing therapies to patients worldwide.
Job Responsibilities
- Preparation of various safety and regulatory reports
- Data collection for report planning and strategy development
- Writing safety reports for global regulatory submissions (e.g., IND, PSUR, PADER, DSUR, RMP)
- Collaboration with clients and stakeholders
- Conducting quality reviews of reports prepared by junior medical writers
- Writing subject narratives for adverse drug reactions and serious adverse events
- Contributing to other regulatory documents such as Clinical Summaries and Common Technical Document Summaries
Qualifications for the Role
- Advanced degree in a relevant scientific field (PharmD, PhD, MD, or equivalent preferred)
- Proven experience in medical writing and safety report writing
- Knowledge of regulatory requirements and pharmacovigilance guidelines
- Strong written and verbal communication skills
- Ability to lead discussions, collaborate with stakeholders, and meet deadlines efficiently
Essential Skills for Success
- Attention to detail for quality review of safety reports
- Ability to conduct and analyze literature searches for report development
- Proficiency in writing clear, concise, and accurate safety documents
- Strong project management skills for handling multiple deliverables
- High level of customer service orientation, fostering a culture of collaboration and innovation
How to Apply
Apply through the following link: Application Link
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