Drug Safety Coordinator
Biopharmaceuticals / Biotherapeutics
- Job Level:
$75,000.00 - $80,000.00
Drug Safety Coordinator needed for a direct hire in Stamford, CT in the biopharmaceuticals industry. As the Drug Safety Coordinator, you will be in charge of managing and tracking receipt of initial and follow-up reports from study sites. The applicant must be able to multi-task and have great interpersonal skills.
Our client is a growing biotechnology company that only strives to make leaps forward in the future of their industry. As a member of this team, you will be a part of a core group that works hard and is dedicated to the progression of their organization.
- 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.
- Bachelor Degree in nursing, pharmacy or a health/science field.
Experience & Skills Required
- 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.
- Experience with use of Adobe Acrobat (Reader and Writer), Microsoft XL and Microsoft Word.
- 3-5 years of relevant database case processing experience.