Safety and Pharmacovigilence Associate

Job Summary/Company:

Sparks Group has Partnered with a growing CRO seeking to add new Safety Associates to their team to support their clinical trials. The safety associate will be responsible for preparing and generating reports for Adverse Events.  If you are looking to start or continue your career supporting clinical documentation and trials, apply below and call 301-926-7800 for more info!

Responsibilities:

• Manage and process Serious Adverse Events (SAEs) 
• Assist in the preparation of reports 
• Generate specified data reports from the database 
• Process and review investigator safety reports and notifications for non-IND adverse event reports 
• Process and review safety narratives for IND and non-IND Adverse Event cases as required 
• Maintain electronic files for the department 
• Query SAE databases

Qualifications/Background Profile:

• B.A./B.S. degree in a relevant field, MS degree in related field a plus 
• Zero (0) to five (5) years of pharmaceutical, biologics, and/or diagnostic experience 
• Drug safety database knowledge required 
• Knowledge of GCPs and current federal regulations and guidelines 
• Excellent oral and written skills including database experience 
• Excellent time management and prioritization skills to meet multiple IND projects’ deadlines required 
• Knowledge of Microsoft Office  

Qualified candidates should send their resume AND call Sparks Group for additional details. Please note, resume must include a valid email address in order to be considered. We look forward to discussing your background, your current job search, and your potential career path with Sparks Group!

Sparks Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, pregnancy, citizenship, family status, genetic information, disability, or protect veteran status.