Fortrea Hiring for Safety Writer

Fortrea Hiring for Safety Writer

Safety Writer
Fortrea
Location: Mumbai, India
Experience: 3 – 4 Years
Qualifications: B.Pharm, M.Pharm, Pharm.D, M.Sc, B.Sc, or other life sciences degrees
Application: Online Application – Verified Job

About Fortrea

Fortrea is a leading global Contract Research Organization (CRO) renowned for its commitment to scientific excellence and clinical development. Operating in nearly 100 countries, Fortrea collaborates with pharmaceutical, biotechnology, and medical device companies to deliver innovative solutions across more than 20 therapeutic areas. With a focus on inclusivity and innovation, Fortrea stands out as a trusted employer in clinical research.

Key Responsibilities

As a Safety Writer at Fortrea, your primary duties include:

Report Preparation and Review

• Authoring and reviewing safety reports such as IND Annual Reports, PSURs, DSURs, and Risk Management Plans.
• Preparing ad hoc reports and conducting benefit-risk evaluations.

Quality Oversight

• Conducting quality reviews of reports prepared by junior writers.
• Ensuring all documentation complies with regulatory standards and guidelines.

Scientific Analysis

• Performing literature searches and reviews for safety documentation.
• Drafting abstracts, summaries, and company comments for safety reporting.

Communication and Collaboration

• Coordinating with internal and external teams for accurate data input.
• Participating in discussions for label updates and regulatory documentation.

Compliance and Process Improvement

• Adhering to pharmacovigilance standards and promoting quality processes.
• Ensuring timely delivery of high-quality safety documents.

Qualifications

• Education: A bachelor’s degree in life sciences is required; advanced degrees (Master’s or Ph.D.) are preferred.
• Experience: Minimum three years in the pharmaceutical industry with at least two years in medical writing.
• Knowledge: Strong understanding of regulatory requirements, pharmacovigilance practices, and ICH-GCP guidelines.

Desired Skills

• Exceptional written and verbal communication skills in English.
• Proficiency in MS Office tools.
• Strong organizational and time-management capabilities.
• Excellent interpersonal skills for teamwork and collaboration.
• Prior scientific or clinical research experience is an advantage.

Why Join Fortrea?

• Inclusive Culture: Be part of a diverse and innovative team.
• Global Impact: Contribute to life-changing therapies across the globe.
• Career Development: Opportunities for professional growth in a leading CRO.

How to Apply

Interested candidates are encouraged to apply online through Fortrea’s career portal. Join Fortrea to make a significant impact on global health. Fortrea Hiring for Safety Writer

Keywords: Safety Writer, Fortrea Jobs, Pharmacovigilance, Clinical Research, Medical Writing, Mumbai Careers, Regulatory Documentation. Fortrea Hiring for Safety Writer

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