Safety Writer

1 month 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 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.

 Write Common Technical Document Summaries including Non Clinical and Clinical Overviews, Clinical Summaries and other regulatory documents as assigned.

 Prepare medical information responses for HCPs

 Author/contribute to signal reports (ad hoc & periodic) & safety issue analysis reports

 Internal and external (client) communication & co-ordination to get the required inputs.

 Participate in creating and updating labels, e.g. Core Data Sheets, USPI, centralized SPCs, Med Guides

 Conduct literature searches for authoring various types of reports or routine surveillance activities. Review and propose updates needed if any to the search strategies. Review the articles selected by other medical writers/junior writers. Author literature abstracts/summaries and propose Company comments.

 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.

 Perform any additional activities as per the project requirement or manager’s discretion on completion of relevant training

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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