- Independently reviews safety related data from clinical trials for content, quality, adherence to regulatory guidance and protocols by collecting, analyzing, and triaging Adverse Events as this position impacts product approval, safety signal identification, and patient safety.
location: North Chicago, Illinois
job type: Contract
salary: $25.00 - 27.04 per hour
work hours: 9 to 5
- Participates in applicable safety surveillance activities for assigned products; and in planning and completion of AdHoc Safety Reports as needed.
- Timely assessment of adverse event coding for consistency and accuracy of coding and ; accurate and effective medical review of safety related CRFs and labs, including communication with Study Designated Physicians by interfacing with study manager, Clinical Research Organizations, Clinical Research Associates, Data Management, Pharmacovigilance
- Supervise tracking of safety related queries to Investigators and assists in handling safety questions from IRB/IEC.
- Assist with Study Safety Review Plan development and implementation in collaboration with Study Designated Physicians and provides Safety overview to Clinical team members, Clinical Research Organizations, Investigators and investigator sites as needed and review study protocols, IND reports, annual reports, Investigator Brochures, Safety sections of the Clinical Reports, Monitoring Plans, IDMC data and other ad hoc reports which include safety data.
- Create narratives of serious adverse events and other identified events of interest in accordance with accepted standards and with high degree of competency.
- Apply knowledge of ICH, FDA, EMA regulations and guidelines affecting drug and disease state, understanding issues to assigned responsibilities with an in depth understanding of product labeling/literature, including safety profile. Understand, implements and improves department SOPs. Clinical knowledge to apply to adverse event data collection and assessment.
- Bachelor's degree with related health science background is required. RN or clinical pharmacy experience strongly preferred.
- 3 years clinical experience with a minimum of 1 year drug safety/pharma experience (or) 2 years clinical experience with a minimum of 3 years drug safety/pharma experience.
- Ability to critically evaluate medical data.
- Ability in accurately and medically presenting; of case data, both orally and in writing.
- Analyze and interpret adverse event data as a component of clinical surveillance activity.
skills: Drug Safety, AD (Adverse Events)
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.