
Safety Writer
4 days ago
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.
**Fortrea is proud to be an Equal Opportunity Employer**:
As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.
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Safety Writer
4 days ago
Mumbai, Maharashtra, India Fortrea Full timeAs 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. With over 19,000 staff...
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Safety Writer
2 days ago
Mumbai, Maharashtra, India Fortrea Full timeAs 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. With over 19,000 staff...
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Senior Safety Writer
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Mumbai, Maharashtra, India Thepharmadaily Full timeJob Description- Write and review various safety reports for global regulatory submissions, including Annual Reports, Periodic Safety Update Reports, Development Safety Update Reports, etc.- Author and review Risk Management Plans, ad hoc reports, Benefit-Risk Evaluation reports, and medical device reports.- Draft Common Technical Document Summaries,...
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Senior Safety Writer
3 weeks ago
Mumbai, Maharashtra, India Thepharmadaily Full timeJob Description- Write and review various safety reports for global regulatory submissions, including but not limited to Annual Reports, Periodic Safety Update Reports, and Development Safety Update Reports.- Author and review Risk Management Plans, adhoc reports, and medical device reports.- Prepare Common Technical Document Summaries including Non-Clinical...
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