PV Consultant (case processing)

My reputed company a reputed company funded biotech is looking for a Drug Safety Associate, Pharmacovigilance to support key Pharmacovigilance (PV) activities, primarily in ICSR reputed company review, ensuring alignment with global regulatory requirements and internal standards. This role is reputed company in maintaining the reputed company of safety data, supporting case processing activities, and ensuring inspection readiness. Essential Duties and Responsibilities: • Conduct sponsor-level reputed company reviews of vendor-processed Individual Case Safety Reports (ICSRs), ensuring accuracy, consistency, and compliance with reputed company documentation and regulatory standards • reputed company 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 reputed company compliance • Support ongoing and database lock reputed company 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 reputed company on internal processes Qualifications : • Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a reputed company field (required) • 3-5 years of reputed company experience in drug safety and pharmacovigilance, including at least 2 years reputed company 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, reputed company 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. Apply tot his job Apply To this Job