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Fortrea

3 - 4 Years

Mumbai

B.Pharm, M.Pharm, Pharm.D, Msc, BSc, Lifesciences

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Job highlights

Work/Life Balance

Time management

challenging projects

Insurance

Fortrea is a globally renowned contract research organization (CRO) with a legacy of scientific rigor and clinical development expertise. Operating in nearly 100 countries, Fortrea provides pharmaceutical, biotechnology, and medical device clients with cutting-edge solutions across more than 20 therapeutic areas. The company is dedicated to transforming drug and device development, ensuring swift delivery of life-changing therapies to patients worldwide. Fortrea fosters an inclusive workplace, making it a standout employer in clinical research and development.

Responsibilities in the Job

As a Safety Writer at Fortrea, you will play a critical role in ensuring compliance and quality in regulatory and safety documentation. Your key responsibilities will include:

  • Report Preparation and Review:
    • Authoring and reviewing various safety reports, including IND Annual Reports, PSURs, DSURs, and Risk Management Plans.
    • Preparing ad hoc reports and benefit-risk evaluations.
  • Quality Oversight:
    • Conducting quality reviews of safety reports prepared by junior or associate writers.
    • Ensuring adherence to regulatory standards and guidelines.
  • Scientific Analysis:
    • Conducting literature searches and reviews for safety reporting.
    • Drafting literature abstracts, summaries, and Company comments.
  • Communication and Collaboration:
    • Coordinating with internal and external stakeholders to ensure timely and accurate data inputs.
    • Participating in discussions for label updates and regulatory documentation.
  • Compliance and Best Practices:
    • Promoting efficient, quality processes for timely deliverables.
    • Adhering to regulatory and pharmacovigilance standards.

Qualifications

Fortrea seeks candidates with the following qualifications:

  • A minimum of a bachelor’s degree in life sciences or equivalent. Advanced degrees (e.g., Master’s or Ph.D.) are preferred.
  • At least three years of experience in the pharmaceutical industry, with two years in medical writing.
  • Comprehensive understanding of regulatory requirements, good pharmacovigilance practices, and ICH-GCP guidelines.

Skills

The ideal candidate will possess:

  • Excellent written and verbal communication skills in English.
  • Proficiency in MS Office applications.
  • Strong organizational and time-management abilities.
  • Exceptional interpersonal skills for effective collaboration.
  • Desirable scientific or clinical research experience.

Application Link

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