Job Title: Principal Safety Writer
Location: Mumbai
Category: Clinical
Job ID: 2447515
Company Overview:
Fortrea is a leading global contract research organization (CRO) that provides a wide range of clinical development, patient access, and technology solutions. Operating in around 100 countries, Fortrea works with pharmaceutical, biotechnology, and medical device companies to drive innovation and speed up the development of new treatments.
Job Overview:
As a Principal Safety Writer, you will lead the preparation, review, and delivery of various safety reports, including risk management and signal detection reports. You'll also oversee the production of safety deliverables involving complex data and safety issues, acting as a technical lead for medical writing teams. Strong client communication and coordination skills are essential to manage expectations and resolve any issues.
Key Responsibilities:
Safety Report Writing & Review:
Write and review safety reports (e.g., Annual Reports, PSURs, Risk Management Plans, Clinical Overviews, etc.) for regulatory submissions.
Ensure high-quality standards and meet project timelines.
Provide oversight and review of co-authors’ work, ensuring quality and consistency.
Client Interaction:
Serve as the primary point of contact for clients regarding report management.
Manage stakeholder expectations, resolve challenges, and propose solutions.
Signal Detection and Safety Analysis:
Lead or participate in the signal management process, including signal evaluation and analysis.
Collaborate with the safety physician to propose risk mitigation strategies.
Scientific Publication:
Author abstracts, posters, and manuscripts for conferences or pharmacovigilance forums.
Support scientific publications and presentations.
Training & Mentoring:
Provide coaching, feedback, and training to team members to ensure high-quality writing standards.
Project & Resource Management:
Contribute to project management, including schedule maintenance, metric tracking, and ensuring compliance with timelines and regulatory standards.
Business Development:
Assist in estimating resource requirements and responding to RFPs.
Compliance & Process Improvement:
Ensure compliance with regulatory requirements and promote quality processes to meet deadlines.
Required Qualifications:
Education:
A degree in Life Sciences or an equivalent field.
Relevant experience may be considered in lieu of educational requirements.
Experience:
At least 5-7 years in the pharmaceutical industry, with 4+ years in medical writing.
Excellent command of written and spoken English, with strong communication skills.
Knowledge of MS Office and organizational skills.
Good understanding of regulatory requirements, pharmacovigilance practices, and ICH GCP guidelines.
Extensive experience with US, EU, and emerging market regulatory submissions.
Preferred Qualifications:
Advanced Degree: PhD or Master's in a relevant field.
Experience in Drug Discovery and Pharmacovigilance: A strong plus.
Physical Demands/Work Environment:
Office or remote environment.
Occasional travel (15%) may be required, including overnight stays depending on project needs.
Fortrea’s Culture:
Fortrea is dedicated to building a culture of Forward Together, Owning It, Upholding Integrity, and Respecting People. We value creative thinkers and problem-solvers who are passionate about transforming the development process for patients worldwide.
Equal Opportunity Employer:
Fortrea is committed to diversity and inclusion, providing equal employment opportunities without discrimination based on race, religion, gender, disability, or other legally protected characteristics.
For more details on how we collect and store personal data, please refer to our Privacy Statement.
If you need accommodations during the application process, contact: taaccommodationsrequest@fortrea.com.
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