• Book-in and perform case processing of serious ICSRs and other qualified case reports in the safety database.
• Manage and track receipt of initial and follow-up reports from study sites.
• Monitor and track reports in the safety desk.
• Manage and track report submission and distribution.
• Manage and track compliance with Pharmacovigilance agreements.
• Support aggregate report preparation activities.
• Participate and support other functional unit activities as assigned.
• Consistently apply case processing and archiving policies and practices per Company SOP.
• Coordinate activities of Drug Safety Functional Unit.
• Support and participate in inspection preparedness activities.
• Safety database case processing experience, preferably Oracle Argus.
• Basic knowledge of relevant FDA/GCP/ICH guidelines and AE reporting requirements.
• Experience with MedDRA and WHODrug coding dictionaries.
• Basic understanding of clinical trial operation.
• Proficiency with use of Adobe Acrobat (Reader and Writer), Microsoft XL and Microsoft Word.
• Must have the ability to multi-task and work with minimal supervision.
• Must be able to solve routine problems and to surface issues constructively.
• Receptive to acquiring new knowledge and learning new skills.
• Highly organized with attention to detail.
• Ability to work within deadlines and prioritize cases accordingly.
• Great interpersonal skills.
• Bachelor Degree in nursing, pharmacy or a health/science field.
• 3-5 years of relevant database case processing experience.