Supervisor, Drug Safety Reporting

Orsini Healthcare•Elk Grove Village, IL

1d•$65,000 - $68,000•Hybrid

About The Position

The Drug Safety Reporting Supervisor will lead the team responsible for ensuring accurate and timely completion of daily adverse event and product complaint documentation to ensure compliance with manufacturer reporting requirements. This role will serve as the subject matter expert and require understanding of the reporting requirements, investigation of the event, meticulous attention to detail, and preparation of the event reports for on time submission of all reports to our manufacturers.

Requirements

Prior experience with Adverse event and product quality complaint reporting preferred
Ability to gather information from medical records and patient notes and enter into adverse event and product complaint forms that meet manufacturer requirements
Proficiency with Microsoft products, including Word, Excel, and Power Point, as well as Adobe Acrobat
Ability to prioritize, multi-task, and manage very time sensitive tasks effectively to meet strict deadlines
High degree of accuracy and attention to detail
Excellent written and verbal communication skills
Pro-active with good analytical skills and problem-solving ability
Self-directed individual with ability to work independently with minimal supervision
Ability to work collaboratively and productively with co-workers across the organization
Familiarity with pharmacy industry and/or previous pharmacy experience preferred

Responsibilities

Provides oversight of drug safety reporting team including completion of adverse event and product quality complaint forms for submission, ensuring compliance with manufacturer requirements and assisting with investigations of adverse events as needed.
Ensures proper record keeping for adverse event and product quality complaint activities, in compliance with manufacturer and regulatory requirements.
Responds to follow up inquiries from manufacturers regarding adverse event and product complaint reports submitted; provide additional information as requested.
Completes weekly, monthly, and quarterly adverse event and product complaint reconciliation as required by manufacturers.
Other related duties as assigned by manage