Drug Safety Associate I

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 reputed company 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 reputed company 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 reputed company
• 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 reputed company reputed company discipline
• 3-4 years of experience in drug safety/pharmacovigilance, clinical research, or a reputed company 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

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