Drug Safety Reporting Supervisor

1w1 week ago

Orsini Healthcare

Elk Grove Village, US · Full-time · $65,000 – $68,000

About this role

Every role at Orsini moves a patient closer to life-changing therapy. The Drug Safety Reporting Supervisor leads the team responsible for accurate and timely completion of daily adverse event and product complaint documentation. This ensures compliance with manufacturer reporting requirements as the subject matter expert.

Day-to-day duties include oversight of adverse event and product quality complaint forms for submission, assisting with investigations, and preparing reports for on-time delivery to manufacturers. Meticulous attention to detail and understanding of reporting requirements are essential. Proper record keeping maintains compliance with manufacturer and regulatory standards.

Orsini is a leader in rare disease and gene therapy pharmacy solutions since 1987, partnering with biopharma, providers, and payers. The mission ensures no patient is left behind through comprehensive commercialization solutions. LIVE IT Core Values guide interactions and commitment to excellence.

Join a team pioneering solutions that simplify access to advanced therapies with compassionate care. Make your next role matter in supporting patients and families. Careers with Orsini deliver real impact in the pharmaceutical industry.

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
Understanding of manufacturer reporting requirements
Experience investigating adverse events
Meticulous attention to detail for accurate documentation
Knowledge of regulatory requirements for drug safety reporting

Responsibilities

Provide oversight of drug safety reporting team including completion of adverse event and product quality complaint forms for submission
Ensure compliance with manufacturer requirements and assist with investigations of adverse events as needed
Maintain proper record keeping for adverse event and product quality complaint activities in compliance with manufacturer and regulatory requirements
Respond to follow-up inquiries from manufacturers regarding adverse event and product complaint reports submitted and provide additional information as requested
Complete weekly, monthly, and quarterly adverse event and product complaint reconciliation as required by manufacturers
Investigate events and prepare reports for on-time submission to manufacturers