Drug Safety Associate I
Job Summary
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
Complete Job Description
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