Safety Writer and Regulatory Specialist

2 weeks ago


Mumbai, Maharashtra, India CSS Fortrea Scientific Pvt Ltd Full time
Safety Writer and Regulatory Specialist

Job Summary:

Fortrea is seeking a skilled Safety Writer and Regulatory Specialist to join our team. As a key member of our safety and pharmacovigilance team, you will be responsible for writing and reviewing various safety reports for global regulatory submissions.

Key Responsibilities:

  • Write and review safety reports, including Annual Reports, Periodic Safety Update Reports, and other documents as assigned.
  • Lead the end-to-end process of report production and ensure quality standards and key timelines are met.
  • Provide oversight to co-authors or team members as applicable and be accountable for the quality of their work.
  • Act as the primary point of contact for clients for all report management activities.
  • Engage in client communication to manage stakeholder expectations and present anticipated challenges.

Requirements:

  • Strong writing and editing skills.
  • Experience in safety and pharmacovigilance.
  • Ability to work independently and as part of a team.
  • Excellent communication and interpersonal skills.

What We Offer:

  • A collaborative and dynamic work environment.
  • Ongoing training and development opportunities.
  • A competitive salary and benefits package.


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