Safety Writer fresher vacancies available at Fortrea

Fortrea, a global contract research organization (CRO), offers Safety Writer fresher vacancies in Mumbai, India. This is an excellent opportunity to join a dynamic team and contribute to groundbreaking clinical development projects.

Safety Writer Fresher vacancies – Fortrea

Safety Writer

Locations: Mumbai, India

Time Type: Full-time

Job Requisition ID: 2441263

End Date: April 17, 2025

As a leading global contract research organization (CRO) with a passion for scientific rigour and decades of clinical development experience. Fortrea provides pharmaceutical, biotechnology, and medical device customers with a wide range of clinical development, patient access, and technology solutions across over 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.

Job Description:

• Perform allied activities such as data collection for report planning, developing strategy, and leading kick-off meetings and round table discussions 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 others), Periodic Safety Update Reports, Periodic Adverse Drug Experience Reports, Development Safety Update Reports, 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, and 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.
• Write subject narratives for adverse drug reactions and serious adverse events.
• Internal and external (client) communication & coordination to get the required inputs.
• Participate in creating and updating labels, such as Core Data Sheets, USPI, centralized SPCs, and Med Guides.
• Conduct literature searches to author 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 consistent, efficient, quality processes to meet timelines and deliverables according to requirements and standard operating procedures and assume accountability.
• Ensure compliance of operations with governing regulatory requirements.
• Create, maintain, and assume accountability for a high customer service culture.
• Per the project requirement or manager’s discretion, complete relevant training and perform any additional activities.

Fortrea is actively seeking motivated problem-solvers 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 life-changing ideas and therapies to needy patients. 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 www.fortrea.com.

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. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based on race, religion, colour, 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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