job summary: As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. We supply prestigious life sciences and biopharma companies with job seekers like you to achieve their business goals. If you're looking for a position where you can serve as an asset to your company while making a difference in others' lives, we have the ideal position for you!
location: Cambridge, Massachusetts
job type: Contract
salary: $46.08 - 54.22 per hour
work hours: 9 to 5
- Able to work with external vendors to support quality and compliant processing of adverse events from clinical trial and spontaneous sources.
- Perform timely monitoring of workflow and reporting parameters to ensure compliance with regulations and performance metrics.
- Support the follow-up activities needed to perform due diligence activities for spontaneous reports.
- Review processed cases to ensure case quality from an Operations perspective.
- Interface with the Quality Operations Department to support appropriate handling of Product Quality Complaints associated with adverse events.
- Coordinate and execute reconciliation of safety data with different stakeholders
- Academic degree in biological or natural science or health care discipline (e.g. BSN, NP, Pharm D, MSc) required.
- Minimum 2 years relevant experience (including industry experience) with a working knowledge of drug safety operations, drug development, ICH and FDA regulatory requirements, and standard medical coding thesauri (MedDRA, WHO DRUG).
- Oracle Argus Safety database experience required
skills: FDA, Quality Assurance, ICH Regulations
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.