Senior Clinical Trial Drug Safety Associate I

Everest Clinical Research; Markham; Hybrid; CAD 70,000 - 110,000; Full time

Job summary

An established industry player in clinical research is seeking a Senior Clinical Trial Drug Safety Associate to join their dynamic team. This role involves leading and mentoring safety associates, ensuring compliance with pharmacovigilance processes, and providing operational support for clinical trials. The ideal candidate will have a strong background in Drug Safety and Pharmacovigilance, with expertise in regulatory guidelines and case processing. This position offers the flexibility of working on-site in Markham or remotely from anywhere in Canada, making it an exciting opportunity for professionals looking to make a significant impact in the field of clinical research.

Qualifications

• 4+ years of experience in Drug Safety/Pharmacovigilance in a pharmaceutical or CRO environment.
• Comprehensive understanding of FDA, Health Canada, and EU safety guidelines.

Responsibilities

• Lead training of safety associates for PV and drug safety activities.
• Perform PV activities and ensure compliance with company SOPs.
• Generate safety data reports from Argus for clients.

Skills

Drug Safety

Pharmacovigilance

Regulatory Guidelines

Case Processing

Communication Skills

Organizational Skills

Education

BS in Clinical or Medical or Life Sciences

Tools

Oracle Argus Safety

Job description

Senior Clinical Trial Drug Safety Associate I

Job Category: Pharmacovigilance and Drug Safety

Requisition Number: SENIO002258

• Posted: January 14, 2025
• Full-Time

Locations

Showing 1 location

Ontario
675 Cochrane Drive
East Tower 4th Floor
Markham, ON L3R0B8, CAN

Everest Clinical Research (“Everest”) is a full-service contract research organization (CRO) 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.

To drive continued success in this exciting clinical research field, we are seeking committed, skilled, and customer-focused individuals to join our winning team as Senior Clinical Trial Drug Safety Associate for our Toronto/Markham, Ontario, Canada on-site location, or remotely from a home-based office anywhere in Canada in accordance with our Work from Home policy.

Key Accountabilities:

• Assume a leader/mentorship role in the training of safety associates for PV and drug safety activities, ensuring compliance with PV processes and procedures as outlined in study level safety plans.
• Receive safety monitoring projects and project information from the direct manager or from the work mentor for the assigned PV projects.
• Perform PV and MDV activities for our clients in compliance with company SOPs, working practices, and regulatory guidelines.
• Provide support to case processing of SAEs and/or pregnancy reports from clients’ ongoing drug clinical trials in a timely manner.
• Participate in the design of SAE report forms for the capturing of safety data in clinical trials.
• Provide operational support to study start-up PV activities, including authoring or peer review of SMPs and related attachments and forms.
• Generate safety data listings or reports from Argus for assigned clients for periodic and ad hoc reporting.
• Ensure compliance with all applicable regulations and timelines for safety case processing and reporting.
• Act as a training resource to staff on case processing and the use of the Argus Safety System.

Qualifications and Experience:

• 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; Oracle Argus Safety database experience is preferred.
• Ability to work independently with little supervision; self-motivated and productive.
• Good organizational skills with the ability to adapt and adjust to changing priorities.
• Strong verbal and written communication skills with the ability to understand and summarize medical terminology.

We thank all interested applicants, however, only those selected for an interview will be contacted.

Everest is committed to upholding the principles of dignity, independence, integration, and equal opportunity. We welcome and encourage applications from people with disabilities, and upon request we will provide accommodations for candidates participating in any part of our recruitment and selection process.