Job Description

Drug Safety Reporting Specialist - Remote Drug Safety Reporting Specialist - Remote About Orsini Rare Disease Pharmacy Solutions Providing compassionate care since 1987, Orsini is a leader in rare disease and gene therapy pharmacy solutions, built to simplify how patients connect to advanced medicines. Through our comprehensive commercialization solutions including a nationwide specialty pharmacy, patient services hub, home infusion and nursing network, and third-party logistics provider, we work with biopharma, providers, and payors to ensure No Patient is Left Behind. Our Mission Orsini is on a mission to be the essential partner for biopharma innovators, healthcare providers, and payers to support patients and their families in accessing revolutionary treatments for rare diseases. Through our integrated portfolio of services, we seek to pioneer comprehensive solutions that simplify how patients connect to advanced therapies while providing holistic, compassionate care so that No Patient is Left Behind. LIVE IT Values At the heart of our company culture, the Orsini LIVE IT core values serve as guiding principles that shape how we interact with each other and those we serve. These values are the driving force behind our commitment to excellence, collaboration, and genuine care in every aspect of our work. Leading Quality, Integrity, Valued Partner, Empathy, Innovation, Team-First Pay Range: $50,000 - $55,000 Position Summary The Drug Safety Reporting Specialist will ensure accurate and timely completion of daily adverse event and product complaint documentation to ensure compliance with manufacturer reporting requirements. This role will 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. Required Knowledge, Skills & Training 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. Essential Job Duties Complete adverse event and product quality complaint forms for submission each day to comply with manufacturer requirements. Assist with investigation of adverse events as assigned. Respond to follow up inquiries from manufacturers regarding adverse event and product complaint reports submitted; provide additional information as requested. Assist with weekly, monthly, and quarterly adverse event and product complaint reconciliation as required by manufacturers. Other compliance related duties as assigned by manager. Employee Benefits BCBSL Medical Delta Dental EyeMed Vision 401k Accident & Critical Illness Life Insurance PTO, Holiday Pay, and Floating Holidays Tuition Reimbursement Seniority level Seniority level Entry level Employment type Employment type Full-time Job function Job function Management and Manufacturing Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Orsini - Rare Disease Pharmacy Solutions by 2x Sign in to set job alerts for “Drug Safety Specialist” roles. Clinical Research Process Improvement Advisor Chicago, IL $85,000.00-$115,000.00 6 days ago Associate I, Clinical Pharmacology Scientific Support & Reporting North Chicago, IL $64,000.00-$122,000.00 1 week ago North Chicago, IL $106,500.00-$202,500.00 2 weeks ago Join Our Talent Community - Clinical Support Specialist Streeterville, IL $65,520.00-$107,120.00 12 hours ago Associate I, Clinical Pharmacology Scientific Support & Reporting Research Study Assistant (Mothers and Babies) Clinical Research Associate - IMM/Cross TA - Chicago, IL (Field Based) Chicago, IL $91,336.00-$114,170.00 2 weeks ago Research Professional, HOPE LAB and RF-CDR Labs Round Lake, IL $80,000.00-$110,000.00 3 weeks ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr Orsini - Rare Disease Pharmacy Solutions

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