[WFH / Pune / Mumbai] Fortrea Hiring Safety Writer

Job Posting: Safety Writer at Fortrea

Company:
Fortrea

About Fortrea:
Fortrea is a global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience. We support pharmaceutical, biotechnology, and medical device customers with a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. With over 19,000 staff operating in more than 90 countries, Fortrea is transforming drug and device development for partners and patients worldwide.

Position:
Safety Writer

Location:
WFH / Pune / Mumbai

Salary:
₹25,000 – ₹55,000 per month

Qualifications:

• B.Pharm, M.Pharm, Pharm.D, M.Sc, B.Sc, Lifesciences

Experience:

• 2 Years

Job Description:

Tasks & Responsibilities:

Data Collection & Planning:

• Perform allied activities such as data collection for report planning.
• Develop strategies and lead kick-off meetings and round table discussions for comment resolution.

Safety Report Writing:

• Write various safety reports (or parts of such reports) for global regulatory submissions.
• Types of reports include:
• Annual Reports (IND and other)
• Periodic Safety Update Reports
• Periodic Adverse Drug Experience Reports
• Development Safety Update Reports
• Risk Management Plans
• Other documents
• Take ownership of assigned deliverables and collaborate with internal/client stakeholders for required inputs.
• Perform quality reviews of safety reports prepared by junior or associate medical writers.
• Author or contribute to ad hoc reports, benefit-risk evaluation reports, and supporting documents for label updates.

Common Technical Document Summaries:

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

Medical Information Responses:

• Prepare medical information responses for healthcare professionals (HCPs).

Signal Reports & Safety Issue Analysis:

• Author/contribute to signal reports (ad hoc & periodic) and safety issue analysis reports.
• Write subject narratives for adverse drug reactions and serious adverse events.

Communication & Coordination:

• Communicate and coordinate internally and externally (with clients) to get required inputs.

Label Creation & Updates:

• Participate in creating and updating labels, such as Core Data Sheets, USPI, centralized SPCs, and Med Guides.

Literature Searches & Surveillance:

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

Process Improvement:

• Implement and promote the use of consistent, efficient, and quality processes to meet timelines and deliverables.
• Ensure compliance of operations with governing regulatory requirements.
• Create and maintain a culture of high customer service.

Additional Activities:

• Perform any additional activities as per the project requirements or manager’s discretion upon completion of relevant training.
• Execute all other duties as needed or assigned.