Senior Pharmacovigilance Associate

Job Summary

Working remotely, the full-time Senior Pharmacovigilance Associate will manage day-to-day drug safety operations, ensuring regulatory compliance while collaborating with internal and external teams to handle serious adverse events.

Key responsibilities

• Oversee drug safety operations with minimal guidance and ensure adherence to procedures
• Collaborate cross-functionally with medical, data, and regulatory teams, as well as external vendors and auditors
• Manage case processing, including serious adverse events (SAE) and suspected unexpected serious adverse reactions (SUSAR)

Required qualifications

• Bachelor's degree in a life sciences field or equivalent professional training and certification in pharmacovigilance
• 3-4 years of experience in Drug Safety or a related field
• Experience with case processing and familiarity with SAE and SUSAR
• Prior experience using the ARGUS safety database, including XML generation and electronic submissions
• Willingness to be on call for after-hours and weekend safety desk coverage