Fortrea Hiring Senior Safety Writer

Fortrea, a renowned contract research organization (CRO) with a global presence, is seeking a talented Remote Senior Safety Writer to join our team in Mumbai, India. This full-time role offers an opportunity to work remotely and significantly contribute to pharmaceutical advancements. If you’re passionate about scientific writing and driving positive changes in healthcare, this position is tailor-made for you.

About Fortrea: Fortrea is a leading CRO dedicated to scientific rigour and clinical excellence. With over 19,000 staff across 90+ countries, we provide innovative solutions in clinical development, patient access, and technology across various therapeutic areas. Our commitment to transforming drug development and improving patient outcomes drives everything we do.

Job Overview: As a Remote Senior Safety Writer at Fortrea, you will be pivotal in authoring and reviewing safety reports and regulatory documents for global submissions. Your contributions will directly impact the success of clinical trials and drug development initiatives. This position offers remote work flexibility, allowing you to collaborate with cross-functional teams and contribute to cutting-edge healthcare solutions.

Summary of Responsibilities:

• Write and review 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, Periodic Benefit-Risk Evaluation Reports, Development Safety Update Report, ACOs, Addendum reports, as assigned.
• Author and review RMPs, ad-hoc reports, Benefit-Risk Evaluation reports and medical device reports.
• Write Common Technical Document Summaries, including Non-Clinical and Clinical Overviews, Clinical Summaries and other regulatory documents as assigned.
• Conducted training for peers and junior team members and provided shadowing opportunities and hands-on experience.
• Draft responses (or parts thereof) to health authority questions or feedback and collaborate with cross-functional stakeholders in managing and tracking such feedback.
• Author/review manuscripts, abstracts, and posters for conferences.
• Prepare medical information responses for HCPs.
• Perform/review signal detection activities. Participate in preparing signalling strategy signal/safety review meetings with clients and help gather safety data for signal evaluation by conducting searches in the safety database, published literature, external databases, etc.
• Author signal reports (ad hoc and periodic) and safety issue analysis reports.
• Act as a writing coach and devise training programs.
• Author/review SOPs/WIs/process documents or sections as applicable.
• If applicable, coordinate activities related to several types of report writing across a team of writers,
• Perform various support activities such as tracking, maintenance of metrics, performing and documenting quality checks and training.
• Assist in the estimation of resource requirements and responding to RFPs as needed.
• Internal and external (client) communication and coordination are needed to get the required inputs.
• Get resolution on issues affecting project deliverables.
• Create and update labels, e.g., Core Data Sheets, USPI, centralized SPCs, and Med Guides. Review and recommend label changes, author proposed label text, and prepare supporting/justification documents.
• Conduct literature searches and reviews for authoring reports and routine surveillance. Review the articles selected by medical writers/junior staff and discuss conflicting review opinions with the safety physician.
• Perform any additional activities at the project’s or manager’s discretion.
• 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.
• And all other duties as needed or assigned.

Qualifications (Minimum Required):

• Minimum of first degree in life sciences (or equivalent).
• Fortrea may consider relevant and equivalent experience instead of educational requirements.
• At least three years of experience in the pharmaceutical industry or medicalizing.

Experience (Minimum Required):

• Excellent command of written and spoken English.
• Good written and verbal communication skills.
• Knowledge of MS Office.
• Good organizational and time management ability.
• Excellent interpersonal skills.
• Scientific or Clinical research experience desirable.
• Good understanding of regulatory requirements, good Pharmacovigilance practices and ICH GCP guidelines.

Preferred Qualifications Include:

• Advanced degree (e.g., PhD or Masters) preferred.

Responsibilities:

• Write and review safety reports for regulatory submissions, including Annual Reports, Periodic Safety Update Reports, and Benefit-Risk Evaluation Reports.
• Author regulatory documents such as Common Technical Document Summaries and Clinical Overviews.
• Conduct trainings and provide guidance to junior team members in medical writing tasks.
• Collaborate with stakeholders to address health authority questions and feedback.
• Participate in signal detection activities and prepare signal reports.
• Coordinate report writing activities across teams and ensure compliance with regulatory requirements.
• Maintain high-quality standards in document preparation and process adherence.

Qualifications and Skills:

• Bachelor’s, Master’s, or Ph.D. degree in a life sciences-related discipline.
• Strong scientific writing skills and familiarity with regulatory requirements.
• Experience in drug development, medical writing, or related fields preferred.
• Excellent communication, collaboration, and organizational abilities.
• Proficiency in conducting literature searches and analyzing data.
• Ability to manage multiple tasks and meet project timelines effectively.

Why Join Fortrea: Joining Fortrea means being part of a dynamic team dedicated to revolutionizing clinical trials and healthcare delivery. As a Remote Senior Safety Writer, you’ll have the opportunity to work on impactful projects, collaborate with industry experts, and contribute to life-changing therapies for patients worldwide. Our inclusive and supportive work culture fosters personal growth and professional development, enabling you to make a meaningful difference in healthcare.

Ready to embark on a rewarding career journey with Fortrea? Apply online today and be part of our innovative team driving healthcare innovations globally.

Apply online at Fortrea Careers.

Fortress is proud to be an Equal Opportunity Employer committed to diversity, inclusion, and excellence in healthcare. We encourage individuals from all backgrounds to apply and contribute to our mission of advancing global healthcare solutions.

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