Drug Safety Coordinator

Ready to play a critical role in patient safety and pharmacovigilance while working independently in a fast-paced global drug safety team?

R&D Partners is seeking a Drug Safety Coordinator to join a pharmaceutical company in the US. This role requires an independent contributor who can efficiently and effectively manage drug safety tasks with minimal oversight. The ideal candidate will have experience with the ARGUS safety database and a strong understanding of Good Clinical Practices (GCP), regulatory guidelines, and company SOPs.

As part of the Global Drug Safety team, the Drug Safety Coordinator will play a critical role in processing adverse event (AE) data, ensuring compliance with regulatory standards, and supporting the Drug Safety Scientist (DSS) and management in fostering a collaborative team environment.

Applicants must have legal authorization to work in the United States.

Responsibilities:

Adverse Event Management:

• Identify, track, and file potential AE information.
• Monitor incoming information for potential AE data and prepare materials for team meetings.
• Enter reports into tracking logs, verify report type (initial, follow-up, or duplicate), and create case folders.
• Remove confidential patient information from source documents and record protocol/site-patient numbers as applicable.
• Provide reports to the designated case owner.

Documentation and Review:

• Serve as the first reviewer of source documents for AE reports within Global Pharmacovigilance.
• Assess report completeness and determine the need for follow-up with reporters.
• Manage receipt, review, and filing of literature sources containing AE information.

Compliance and Protocol Adherence:

• Maintain a basic understanding of clinical study protocols and scopes of work.
• Ensure strict adherence to GCP guidelines and regulatory reporting requirements.

Key Skills and Requirements:

• Experience with ARGUS safety database preferred.
• Strong knowledge of Good Clinical Practices (GCP) and regulatory guidelines.
• Ability to work independently with minimal supervision.
• Excellent organizational and communication skills.
• Familiarity with clinical study protocols and pharmacovigilance processes.

For more information, please contact William Tyler.

If you are interested in applying to this exciting opportunity, then please click ‘Apply’ or to speak to one of our specialists visit the ‘Contact Us’ page.

R&D Partners is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. R&D Partners is acting as an Employment Agency in relation to this vacancy.

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