Safety Writing Assistant Ii

3 weeks ago

Mumbai Maharashtra, India Fortrea Full time

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 19,000 staff 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 generation of outputs/reports from the databases or safety systems, distribution of data requests, sales data calculations, regulatory website searches, collating report planning materials, etc.
- Author parts of various safety reports for global regulatory submissions, including but not limited to Annual Reports (IND and other), Periodic Safety Update Reports, Periodic Adverse Drug Experience Reports, Periodic Benefit-Risk Evaluation Reports, Development Safety Update Reports, Risk Management Plans, and other documents as assigned.
- Develop the assigned report parts, examples of which may include sections with majorly pre-populated template text, re-use of content from other documents, or low to medium complexity of safety analyses. Review and annotate line listings, prepare case narratives or data summaries, and present data per approved strategy. Participate in comment resolution

discussions for the assigned sections.
- Support medical writers in signal detection activities, including data cleaning, review, and annotation of line listings, creating supporting material for signal review meetings, and preparing parts of signal reports.
- Support the preparation of ad hoc reports such as safety issue analysis reports, and justification/supporting documents for label updates.
- Write sections of Common Technical Document Summaries including Non-Clinical and Clinical Overviews, Clinical Summaries and other regulatory documents as assigned.
- Conduct literature searches for authoring several types of reports. Review the search outputs for selection of articles potentially relevant for inclusion in safety reports. Prepare abstracts or summaries of the selected articles.
- Perform any additional activities as per the project requirement or manager’s discretion on completion of relevant training.
- 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.
- And all other duties as needed or assigned.

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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