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Fortrea is currently hiring for a Safety Writer position in Mumbai, India. If you are interested in applying for the role, please check details and apply.
Safety Writer
đź“ŤLocation: Mumbai India
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 a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
Perform allied activities such as data collection for report planning, developing strategy, and leading kick-off meetings and round table discussion for comment resolution.
• Write various safety reports (or part of such reports) for global regulatory submissions, including but not limited to Annual Reports (IND and other), Periodic Safety Update Reports, Periodic Adverse Drug Experience Reports, Development Safety Update Report, Risk Management Plans, and other documents. Take ownership of the assigned deliverables and collaborate with internal/ client stakeholders and the client to get the required inputs.
• Perform quality review of the safety reports prepared by junior or associate medical writers.
•Author or contribute to ad hoc reports, benefit-risk evaluation reports, justification/supporting documents for label updates.
Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.
