Job Description

Our client a prestigious CRO is looking for a drug safety associate to become familiar with all applicable regulations and company SOPs relevant to safety monitoring, adverse events and serious adverse event reporting in clinical studies and to become proficient and self-sufficient in conducting all procedures in relation to safety monitoring.

JOB FUNCTIONS/RESPONSIBILITIES:

• Familiarity with company SOPs, Study Specific Adverse Event Reporting SOPS, and appropriate regulations.
• Document and process serious adverse event reports.
• Maintain adverse event database/ tracking system and paper files.
• Safety review of clinical data.
• Be cost effective.
• Keep the person to whom the Drug Safety Associate reports informed of any safety related issues within the department which require attention.
• Nursing/ paramedical background and relevant experience (at least 1 year).
• Computer literacy.
• Good oral and written communication skills.

Qualifications/Skills Required

CANDIDATE REQUIREMENTS

• Nursing/ paramedical background and relevant experience (at least 1 year).
• Computer literacy.
• Good oral and written communication skills.