Clinical Safety Specialist
Proclinical is currently recruiting for a Clinical Safety Specialist with a biopharmaceutical company located in Chicago, IL.
- Medical Review, which involves in-house review of Case Report Forms (CRFs) including query resolution and addenda writing, QA of data listings
- May manage the activities of regional contract CRAs, and organizes the files and budgets associated with several clinical studies.
- Provide medical support which may include: Adverse Event Reporting - the investigation and reporting of medical product experiences, in depth investigation of medical adverse events and works with Medical Affairs, Clinical, and Regulatory Affairs in the preparation of documentation on adverse events for the FDA; or Medical Communication which includes writing standard and custom responses to communication requests, in-depth assistance to the medical and lay community by responding to inquiries with medical/scientific information that is more complex and requires more data than is supplied in the package insert or the standard letter database.
- May provide training internally and at investigator meetings on safety issues, responsible for serious adverse events and CRF completion, writing study summaries, and review protocols, study summary investigator brochures and IND annual updates for safety data verification.
- Support product complaint handling processes for clinical supplies.
- Interface with external clinical investigators, drug depots/distributors, and partner companies to obtain complaint information.
- Initiate new product complaint records in the electronic system, determine investigation needs based on complaint details, drive investigation activities, and document the final report.
Skills and Requirements:
- Bachelor's degree with at least 3 years of experience in pharmaceutical quality/complaint/CAPA role
- BSN/RN with clinical complaint experience
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Mary Jacobs at 312-291-4181or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.