PV Consultant (case processing)
My client a well funded biotech is looking for a Drug Safety Associate, Pharmacovigilance to support key Pharmacovigilance (PV) activities, primarily in ICSR quality review, ensuring alignment with global regulatory requirements and internal standards. This role is instrumental in maintaining the integrity of safety data, supporting case processing activities, and ensuring inspection readiness. Essential Duties and Responsibilities:
- Conduct sponsor-level quality reviews of vendor-processed Individual Case Safety Reports (ICSRs), ensuring accuracy, consistency, and compliance with source documentation and regulatory standards
- Perform and support PV activities outlined in Safety Management Plans (SMPs), including tracking safety submissions, managing site query escalations, maintaining distribution lists, ensuring adherence to case processing timelines, tracking vendor quality compliance
- Support ongoing and database lock related Serious Adverse Event (SAE) reconciliation activities
- Support review of MedDRA and WHODrug coded medical terminology listings
- Maintain awareness of global PV trends and regulatory changes to proactively assess impact on internal processes
Qualifications :
- Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a related field (required)
- 3-5 years of progressive experience in drug safety and pharmacovigilance, including at least 2 years within a clinical trial environment
- Proficient in clinical case processing, including medical terminology, MedDRA and WHODrug coding, and narrative writing
- In-depth knowledge of global PV regulations and guidelines (e.g., FDA, EMA, MHRA, PMDA, ICH, GVP), and familiarity with aggregate reporting processes
- Experience working with safety databases (e.g., Argus, ArisG, Veeva Vault Safety)
This role is a 12 month contract position and fully remote 40 hours per week. Candidates must have experience in phase 1 – phase 3 clinical trials.