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
Requirements:
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
Job description
The Science Team at Russell Tobin is supporting a world-class organization that has an opening for “Drug Safety Associate”
Key Responsibilities
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.
Russell Tobin offers eligible employee’s comprehensive healthcare coverage (medical, dental, and vision plans), supplemental coverage (accident insurance, critical illness insurance and hospital indemnity), a 401(k)-retirement savings, life & disability insurance, an employee assistance program, identity theft protection, legal support, auto and home insurance, pet insurance, and employee discounts with some preferred vendors.
