Global Regulatory Safety Expert

3 weeks ago


Mumbai, Maharashtra, India CSS Fortrea Scientific Pvt Ltd Full time
Job Title: Principal Safety Writer

At CSS Fortrea Scientific Pvt Ltd, we seek a skilled Principal Safety Writer to join our team of experts in the field of clinical development. This role requires a strong background in writing and reviewing safety reports for global regulatory submissions.

Key Responsibilities:

  • Develop and review safety reports for clients, including Annual Reports, Periodic Safety Update Reports, and other documents as assigned.
  • Lead the end-to-end process of report production, ensuring quality standards and key timelines are met.
  • Provide oversight to co-authors or team members, ensuring the quality of their work and contributions.
  • Act as the primary point of contact for clients, managing stakeholder expectations, presenting challenges, and escalating unresolved issues.
  • Author and review RMPs, ad hoc reports, and other safety-related documents.
  • Participate in signal management processes, providing inputs for developing signal strategies and retrieving data from safety databases and scientific literature.

Requirements:

  • Strong writing and communication skills.
  • Experience with safety reporting and regulatory submissions.
  • Ability to work independently and lead teams.
  • Strong attention to detail and quality control.

We offer a collaborative work environment, opportunities for growth and development, and a competitive salary and benefits package.



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