Clinical Safety Associate

1 week ago


Bengaluru, Karnataka, India Lifelancer Full time
Job Summary

We are seeking a Clinical Safety Associate to join our team as a Narrative Writer. This role involves managing and developing individual case narratives describing adverse events for inclusion in regulatory submissions and safety reports.

About the Role

In this position, you will be responsible for supporting clinical submission narrative writing for Phase 1-4 clinical trials in accordance with client SOP. You will provide thorough checks of all data points and ensure that narratives meet client requirements.

Key Responsibilities
  • Write high-quality narratives based on data listings and safety reports
  • Manage and develop individual case narratives describing adverse events
  • Ensure narratives meet client SOP and Style Guide requirements
  • Provide finalized narratives incorporating client review comments and Quality Control findings
  • Develop Narrative Table of Contents for each project/study
Qualifications

The ideal candidate will have a Master's degree in Pharmacy and 1-3 years of experience in pharmacovigilance operations or a related field. Strong problem-solving skills, written and verbal communication abilities, and results-oriented approach are essential for success in this role.

What We Offer

As a Clinical Safety Associate at Lifelancer, you will have the opportunity to work on exciting projects and develop your skills in a dynamic environment. Our company provides opportunities for professional growth and development, and we offer a competitive salary range of $80,000 - $110,000 per year, depending on experience.



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