Senior Clinical Trial Drug Safety Associate

1 week ago


Toronto, 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 key member of our clinical research organization, you will play a critical role in ensuring the safety and efficacy of our clients' products.

Key Responsibilities:
  • Assume a leadership role in training and mentoring safety associates on PV and drug safety activities, ensuring compliance with PV processes and procedures.
  • Receive and manage safety monitoring projects, including study protocols, SMPs, and case report forms.
  • Perform PV and MDV activities for our clients, adhering to company SOPs, working practices, and regulatory guidelines.
  • Support case processing of SAEs and pregnancy reports, including case triage, data entry, narrative writing, and quality review.
  • Participate in the design of SAE report forms and provide operational support to study start-up PV activities.
  • Generate safety data listings and reports from Argus for assigned clients.
  • Ensure consistency of safety data between clinical and safety databases.
  • Comply 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.
  • Experience with safety case processing in clinical trials and Oracle Argus Safety database.
  • Ability to work independently with strong organizational skills and attention to detail.
  • Excellent communication and teamwork skills.
About Us:

Everest Clinical Research Services Inc is a full-service contract research organization providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the best-known companies and work with many of the most advanced drugs, biologics, and medical devices in development today.



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