Drug Safety Reporting Specialist

About Orsini

Established in 1987, Orsini specializes in rare disease and gene therapy pharmacy solutions, aiming to simplify patients' access to advanced medicines. The company partners with biopharmaceutical innovators, healthcare providers, and payers through services like a nationwide specialty pharmacy, patient services hub, home infusion and nursing networks, and third-party logistics to uphold their mission of ensuring no patient is left behind.

Mission and Core Values

Orsini’s mission is to be an essential partner supporting patients and families in accessing revolutionary treatments for rare diseases. Their integrated services focus on simplifying patient connection to advanced therapies, offering holistic and compassionate care grounded in their LIVE IT core values, which guide collaboration, care, and excellence.

Position Summary

The Drug Safety Reporting Specialist is responsible for accurately and promptly completing documentation related to adverse events and product complaints to meet manufacturer requirements. This role requires a detailed understanding of reporting standards, investigative support on events, and timely report submission.

Key Responsibilities

• Prepare daily forms documenting adverse events and product quality complaints in compliance with manufacturers’ standards.
• Assist with investigations into adverse events as assigned.
• Address manufacturer follow-up questions regarding submitted reports and provide required additional information.
• Support weekly, monthly, and quarterly reconciliation of adverse event and complaint data as mandated.
• Carry out additional compliance duties as delegated by management.

Required Skills and Qualifications

• Preferred prior experience in adverse event and product quality complaint reporting.
• Ability to extract and enter relevant data from medical records and patient notes into required forms meeting manufacturer criteria.
• Proficiency in Microsoft Word, Excel, PowerPoint, and Adobe Acrobat.
• Strong prioritization and multitasking skills to manage highly time-sensitive tasks and meet strict deadlines.
• Exceptional accuracy and attention to detail.
• Excellent verbal and written communication abilities.
• Proactive mindset with solid analytical and problem-solving skills.
• Self-motivated and capable of working independently with minimal supervision.
• Collaborative approach to working across teams.
• Background or familiarity with the pharmacy or pharmaceutical industry is preferred.

Compensation and Work Location

This position offers an annual salary range of $55,000 to $58,000. It is a hybrid role based in Elk Grove Village, Illinois.

Employee Benefits

• Health benefits including medical, dental, and vision coverage.
• 401(k) retirement plan with employer matching contributions.
• Accident and critical illness insurance coverage.
• Company-sponsored life insurance options.
• Generous paid time off, including holidays and floating holidays.
• Tuition reimbursement program available.

Equal Opportunity and Compliance

Orsini is committed to equal employment opportunity regardless of race, creed, color, national origin, age, sex, marital status, orientation, or disability where reasonable accommodation is applicable. The workplace complies with the Americans with Disabilities Act, and all hires are verified through the federal E-Verify system to confirm employment eligibility.