Safety Writer
Safety Writer
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Job Description
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. With over 19000 staff conducting operations in more than 90 countries Fortrea is transforming drug and device development for partners and patients across the globe.
Implement and promote use of consistent efficient and quality processes to meet timelines and deliverables according to requirements and standard operating procedures and assume accountability for the deliverables
Ensure compliance of operations with governing regulatory requirements
Create maintain and assume accountability for a culture of high customer service
Efficiency in conducting literature searches for authoring various types of reports
Author/review various safety reports (or part of such reports) for global regulatory submissions for Fortreas clients including Annual Reports (IND and other) Periodic Safety Update Reports Periodic Adverse Drug Experience Reports Periodic BenefitRisk Evaluation Reports Bridging reports and other clinical documents as assigned.
Perform/review Signal detection activities
Author/ review RMP ad hoc reports Safety Update reports BenefitRisk Evaluation CCDS supporting document ACOs Addendum reports
Perform allied activities like: Generation of line listings and summary tabulation CFIs CFCs
Search literature databases for relevant information recommend label changes author proposed label text and prepare supporting/justification document
Author/review SOPs/WIs/process documents or sections as applicable
Impart/conduct Trainings for peers and team members
Any additional activities as per the project requirement or managers discretion on completion of relevant trainings
Fortrea is actively seeking motivated problemsolvers 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 lifechanging 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. For more information about Fortrea visit
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.
For more information about how we collect and store your personal data please see ourPrivacy Statement
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Remote Work :
No
Employment Type
Full Time
