Fortrea Hiring for Safety Writer in Pune for authoring safety reports, signal detection documents, and regulatory submissions. Apply online before deadline.
Location: Pune
Job Type: Full Time
Last Date to Apply: November 24, 2025
Job Requisition ID: 255075
Application Mode: Online
Fortrea, a globally respected clinical research organization, is inviting applications for the position of Safety Writer. This is an excellent opportunity for experienced medical writers and safety professionals who want to advance their careers in pharmacovigilance, regulatory writing, and global safety documentation. Fortrea Hiring for Safety Writer in Pune
As part of Fortrea’s medical writing and drug safety team, the Safety Writer plays a crucial role in developing high-quality aggregate safety reports, risk management documentation, and signal detection analyses submitted to global regulatory authorities. The role demands strong scientific writing skills, attention to detail, and the ability to collaborate with clients and internal safety experts.
This long-format post provides a complete overview of the job responsibilities, required skills, preferred qualifications, and detailed application steps. Fortrea Hiring for Safety Writer in Pune
About the Role – Safety Writer
The Safety Writer is responsible for preparing, reviewing, and managing safety documents required for compliance with global regulatory guidelines. These documents help organizations demonstrate product safety, manage risk, detect signals early, and maintain regulatory compliance throughout the product lifecycle. Fortrea Hiring for Safety Writer in Pune
In this role, you will be involved in:
- Authoring clinical and safety reports
- Preparing signal detection documentation
- Leading discussions with clients
- Managing timelines and deliverables
- Supporting peer writers
- Ensuring compliance with regulatory and ICH guidelines
The Safety Writer is central to maintaining the quality and consistency of medical writing deliverables across safety surveillance, aggregate reporting, and risk management functions. Fortrea Hiring for Safety Writer in Pune
Detailed Job Responsibilities
Here is a comprehensive breakdown of the key responsibilities associated with this role:
1. Aggregate Safety Report Writing
You will write and manage various global regulatory safety documents, including:
- Annual Reports (IND and others)
- Periodic Safety Update Reports (PSUR)
- Periodic Adverse Drug Experience Reports (PADER)
- Development Safety Update Reports (DSUR)
- Risk Management Plans (RMP)
- Benefit-risk assessment reports
- Supporting justification documents for label updates
These documents require coordination, scientific analysis, literature evaluation, and precise writing to meet regulatory expectations. Fortrea Hiring for Safety Writer in Pune
2. Report Planning and Strategy Development
Before any safety report is written, extensive planning is required. You will:
- Collect key data for report preparation
- Create writing strategies
- Define timelines and workflow
- Lead kick-off meetings with clients
- Conduct round-table discussions for comment resolution
This ensures clarity between all stakeholders and smooth execution of complex reports. Fortrea Hiring for Safety Writer in Pune
3. Quality Review and Oversight
An important part of the Safety Writer role is providing quality review and oversight of documents prepared by peers or junior associates. This includes:
- Ensuring accuracy and clarity
- Checking compliance with internal SOPs and global guidelines
- Ensuring correct interpretation of safety data
- Providing constructive feedback
This quality review supports the delivery of high-standard, audit-ready documents.
4. Support for Complex Reports
For large, multi-component safety reports, you may act as:
- A co-author
- A reviewer
- A project coordinator
This includes steering communication between internal teams, clients, and safety specialists. Fortrea Hiring for Safety Writer in Pune
5. Signal Detection Documentation
You will author or contribute to:
- Ad hoc signal reports
- Routine signal detection documents
- Safety issue analysis reports
Signal detection is essential for identifying early safety concerns and ensuring patient protection.
6. Scientific Literature Search and Review
A major responsibility includes performing literature searches and reviewing scientific publications to: Fortrea Hiring for Safety Writer in Pune
- Identify safety-related information
- Summarize findings
- Prepare abstracts or summaries
- Recommend updates to search strategies
- Review literature selected by junior writers
Literature review ensures reports are backed by current scientific evidence. Fortrea Hiring for Safety Writer in Pune
7. Writing Narratives and Case Summaries
You will write:
- Subject narratives for serious adverse events
- Adverse drug reaction (ADR) summaries
- Clinical safety narratives as needed
These narratives form part of regulatory submissions and safety assessments. Fortrea Hiring for Safety Writer in Pune
8. Preparing CTD Summaries and Other Regulatory Documents
You will contribute to or author:
- Non-Clinical Overviews
- Clinical Overviews
- Clinical Summaries
- Other CTD (Common Technical Document) modules
These documents are essential for global marketing authorization submissions.
9. Labeling Support
You will support safety-related labeling activities such as:
- Updating Core Data Sheets (CDS)
- Updating US Prescribing Information (USPI)
- Contributing to Med Guides
- Supporting centralized SPC updates
Labeling accuracy ensures physicians and patients receive correct safety information.
10. Communication and Coordination
You will maintain frequent communication with internal teams and clients to:
- Collect input
- Resolve queries
- Manage expectations
- Ensure timely reviews and approvals
Strong communication ensures smooth and transparent project execution. Fortrea Hiring for Safety Writer in Pune
11. Compliance and Quality Assurance
You must ensure:
- Compliance with regulatory guidelines
- Adherence to safety reporting SOPs
- Quality, accuracy, and scientific integrity of documents
- Strict timelines and deliverable commitments
Safety writing requires high attention to regulatory detail and consistency.
12. Additional Responsibilities
Other responsibilities may include: Fortrea Hiring for Safety Writer in Pune
- Participating in internal process improvement
- Supporting training activities
- Assisting managers on request after completing relevant training
- Performing any other role-based activities assigned
Minimum Qualifications Required
Candidates must meet the following criteria:
Education:
- Minimum first degree in Life Sciences or equivalent (e.g., Pharmacy, Biotechnology, Microbiology, Biochemistry).
- Fortrea may consider equivalent work experience in place of educational requirements.
Experience:
- Minimum 3 years of industry experience in the pharmaceutical domain.
- At least 2 years of experience in medical writing, especially safety or regulatory writing.
Essential Skills Required
- Excellent command of written and spoken English
- Strong scientific writing and editing skills
- Ability to understand clinical and safety data
- Good knowledge of pharmacovigilance, regulatory guidelines, and ICH-GCP
- Strong time management and organizational skills
- Ability to meet strict deadlines
- Strong interpersonal and communication skills
- Proficiency in MS Office
Preferred Qualifications
- Advanced degree such as Master’s or PhD preferred
- Experience in clinical research or pharmacovigilance
- Experience working directly with global clients
Work Environment
- Primarily office-based or remote
- Travel up to 5% may be required depending on project needs
- Overnight travel possible when necessary
Why Consider This Role?
This role is an excellent opportunity for candidates aspiring to build a long-term career in:
- Medical writing
- Pharmacovigilance
- Regulatory documentation
- Drug safety
- Scientific communication
You will gain exposure to global regulatory requirements, high-impact safety documents, and complex medical writing projects. Fortrea Hiring for Safety Writer in Pune
How to Apply
Candidates who wish to apply for the Safety Writer position can follow the steps below:
Application Steps
- Visit the official Fortrea careers website.
- Search for Safety Writer – Job ID 255075.
- Select the Pune location.
- Click on Apply Now.
- Fill in the online application form with accurate details.
- Upload your updated resume.
- Submit the application before November 24, 2025.
After submission, keep track of your email for interview updates or further instructions. Fortrea Hiring for Safety Writer in Pune
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