Fortrea
Are you a skilled medical writer with a passion for pharmacovigilance and regulatory affairs? Fortrea, a leading global contract research organization (CRO), is offering an incredible opportunity for a Safety Writer in Mumbai. If you have experience in authoring safety reports and collaborating with global stakeholders, this role is for you!
Safety Writer
Location: Mumbai
Job Time: Full time
Job ID: 2443863
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 ~100 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.
About Fortrea
Fortrea is a global CRO with decades of clinical development expertise, providing innovative solutions in pharmaceutical, biotechnology, and medical device industries. With operations spanning across ~100 countries, Fortrea is revolutionizing drug and device development to improve healthcare outcomes worldwide.
