Clinical Safety Expert

1 day ago


Pune, Maharashtra, India TransPerfect Full time

Estimated salary: $80,000 - $110,000 per year.

About the Role

We are seeking a highly skilled Clinical Safety Expert to join our team at TransPerfect. As a key member of our Pharmacovigilance Specialist team, you will collaborate with cross-functional teams to analyze and report on safety findings related to patient safety and efficacy of our clients' drugs and products.

The ideal candidate will have a strong background in medical terminology, pharmacology, and clinical research. You will be responsible for ensuring effective and clear documentation and communication of safety information to share with clients directly or report directly to health authorities globally.

Key Responsibilities
  • Analyze adverse event data and prepare safety reports for submission to various health authorities
  • Maintain data integrity and promote audit compliance by following Good Documentation Practice (GDP) standards
  • Conduct safety document or data analysis and adhere to project timelines
  • Collaborate with internal stakeholders to identify opportunities for process improvements and implement changes
  • Stay up-to-date with regulatory requirements and industry developments
Requirements
  • Doctor of Pharmacy (Pharm D) or Doctor of Medicine (MD) from an accredited institution
  • 2-3 years of experience in drug safety
  • Excellent written and oral communication skills
  • Strong knowledge of English grammar and spelling, as well as medical terminology
  • Familiarity with Good Clinical Practice (GCP), GDP, and International Conference on Harmonization (ICH) guidelines
About Us

TransPerfect is a leading provider of translation services and solutions. We are committed to helping our clients succeed in a rapidly changing global marketplace.



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