Job Description

Drug Safety Associate

The Science Team at Russell Tobin is supporting a world-class organization that has an opening for Drug Safety Associate. Key responsibilities include:

• Perform end-to-end case processing activities including triage, data entry, and report distribution
• Assess and process all adverse event case types in compliance with regulatory standards
• Conduct case triage to determine priority levels when required
• Identify adverse events, seriousness, and labeledness; evaluate incoming data for reportability
• Perform coding using MedDRA, WHO-DRUG, and company product dictionaries
• Identify follow-up requirements and obtain additional information via appropriate channels (email, phone, letters)
• Conduct quality control (QC) activities, reconciliation, and CRO oversight tasks as needed
• Manage workload through workflow systems, prioritizing high-impact cases
• Support pharmacovigilance inspections and audits, including interviews and data provision
• Monitor vendor KPIs/KQIs in alignment with company standards

Education & Experience Requirements:

• Bachelor's degree in Life Sciences or Healthcare (e.g., Nursing, Pharmacy); advanced degree preferred
• Minimum 5 years of experience in a pharmaceutical/biopharmaceutical environment
• At least 3 years of experience in Drug Safety Operations
• Experience managing or overseeing CRO case processing teams preferred
• Experience with US FDA pharmacovigilance inspections preferred

Required Skills & Competencies:

• Strong understanding of US and global pharmacovigilance regulations and best practices
• Proficiency in MedDRA coding and safety databases

Additional Information:

• Location: REMOTE
• Duration: 12 Months
• Pay rate: $35-$37/hour

Must be authorized to work in the United States.

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