Senior Clinical Trial Drug Safety Associate

1 month ago

Markham, Ontario, Canada Everest Clinical Research Services Inc Full time
Job Title: Senior Clinical Trial Drug Safety Associate

Everest Clinical Research Services Inc is seeking a highly skilled and experienced Senior Clinical Trial Drug Safety Associate to join our team. As a Senior Clinical Trial Drug Safety Associate, you will be responsible for providing leadership and guidance to junior team members, ensuring compliance with regulatory requirements, and delivering high-quality safety data to our clients.

Key Responsibilities:
  • Assume a leadership role in training and mentoring junior team members on safety procedures and protocols.
  • Receive and process safety monitoring projects, ensuring timely and accurate delivery of safety data to clients.
  • Perform pharmacovigilance and medical device vigilance activities in compliance with company SOPs and regulatory guidelines.
  • Provide support to case processing of serious adverse events and pregnancy reports, including data entry, narrative writing, and quality review.
  • Participate in the design of safety report forms and related attachments.
  • Generate safety data listings and reports from Argus for assigned clients.
  • Perform reconciliation activities to ensure consistency of safety data between clinical and safety databases.
  • Ensure compliance with all applicable regulations and timelines for safety case processing and reporting.
Requirements:
  • BS (or equivalent) degree in Clinical or Medical or Life Sciences.
  • 4 years relevant work experience in Drug Safety/Pharmacovigilance in a pharmaceutical or CRO environment.
  • Comprehensive understanding of FDA, Health Canada, and/or EU legislation and GCP/GVP/ICH safety guidelines for investigational and marketed products.
  • Experience with safety case processing in clinical trials.
  • Prior experience with a safety database, including case processing and generating reports/line listings from the database.
  • Familiar with E2B (XML) format for safety reporting to regulatory agencies.
What We Offer:

We offer a dynamic and challenging work environment, opportunities for professional growth and development, and a competitive compensation package.

Everest Clinical Research Services Inc is an equal opportunities employer and welcomes applications from diverse candidates.

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