To support a growing late-stage portfolio, the part-time contract Drug Safety Associate I will manage end-to-end intake and data entry in Veeva Vault Safety, ensuring expedited regulatory submissions meet ICH E2B and FDA/EMA timelines while building pharmacovigilance expertise in a fully remote environment.
Key Responsibilities
• Receive, triage, and process incoming ICSRs in Veeva Vault Safety, including MedDRA and WHODrug coding for adverse events
• Maintain accurate case records and execute follow-up requests for missing information to ensure data integrity
• Assist in regulatory compliance by preparing line listings and participating in audit readiness activities
Required Qualifications
• Bachelor's degree in Pharmacy, Nursing, Life Sciences, or a related healthcare discipline
• 3-4 years of experience in drug safety/pharmacovigilance, clinical research, or a related regulated life-sciences role
• Familiarity with ICH E2B, FDA 21 CFR 312.32, and EMA GVP Module VI reporting requirements
• Working knowledge of MedDRA terminology
• Excellent written English for narrative authoring