- 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.
- Must have the ability to multi-task and work with minimal supervision.
- Must be able to solve routine problems and to surface issues constructively.
- Must be able to make basic decisions with understanding of the consequences.
- Achieve personal objectives while meeting departmental standards of performance.
- 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.
- Fluent in written and spoken English.
- 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.
- Bachelor Degree in nursing, pharmacy or a health/science field.
- 3-5 years of relevant database case processing experience.