Drug Safety Reporting Specialist - Remote

Freddie Mac; United States; Remote; USD 50,000 - 55,000; Full time

Job summary

A leading company in rare disease pharmacy solutions is seeking a Drug Safety Reporting Specialist to ensure accurate documentation of adverse events and product complaints. This remote role requires meticulous attention to detail and effective communication skills. The ideal candidate will have experience in reporting protocols and the ability to manage time-sensitive tasks. Join a team committed to compassionate care and innovative solutions for patients with rare diseases.

Benefits

BCBSL Medical

Delta Dental

EyeMed Vision

401k

Accident & Critical Illness

Life Insurance

PTO, Holidays, and Floating Holidays

Tuition Reimbursement

Qualifications

• Experience with adverse event and product quality complaint reporting preferred.
• Familiarity with the pharmacy industry and/or previous pharmacy experience preferred.

Responsibilities

• Complete adverse event and product complaint forms daily.
• Assist with investigation of adverse events as assigned.
• Respond to follow-up inquiries from manufacturers regarding submitted reports.

Skills

Attention to Detail

Communication

Analytical Skills

Problem Solving

Time Management

Tools

Microsoft Word

Excel

PowerPoint

Adobe Acrobat

Job description

Drug Safety Reporting Specialist - Remote

Description

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 aims 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. We seek to pioneer comprehensive solutions that simplify patient access to advanced therapies while providing holistic, compassionate care, ensuring No Patient is Left Behind.

LIVE IT Values

Our company culture is guided by the Orsini LIVE IT core values: Leading Quality, Integrity, Valued Partner, Empathy, Innovation, and Team-First. These principles drive our commitment to excellence, collaboration, and genuine care.

Pay Range: $50,000 - $55,000

Position Summary

The Drug Safety Reporting Specialist will ensure the accurate and timely completion of adverse event and product complaint documentation to comply with manufacturer reporting requirements. This role requires understanding reporting protocols, investigating events, meticulous attention to detail, and preparing reports for on-time submission to manufacturers.

Required Knowledge, Skills & Training

• Experience with adverse event and product quality complaint reporting preferred.
• Ability to gather information from medical records and patient notes and enter data into manufacturer-compliant forms.
• Proficiency with Microsoft Word, Excel, PowerPoint, and Adobe Acrobat.
• Ability to prioritize, multitask, and manage time-sensitive tasks effectively.
• High accuracy and attention to detail.
• Excellent written and verbal communication skills.
• Proactive with strong analytical and problem-solving skills.
• Self-directed with the ability to work independently.
• Ability to collaborate effectively with colleagues across the organization.
• Familiarity with the pharmacy industry and/or previous pharmacy experience preferred.

Essential Job Duties

• Complete adverse event and product complaint forms daily to meet manufacturer requirements.
• Assist with investigation of adverse events as assigned.
• Respond to follow-up inquiries from manufacturers regarding submitted reports; provide additional information as needed.
• Assist with weekly, monthly, and quarterly adverse event and complaint reconciliations.
• Perform other compliance-related duties as assigned by the manager.

Employee Benefits

• BCBSL Medical
• Delta Dental
• EyeMed Vision
• 401k
• Accident & Critical Illness
• Life Insurance
• PTO, Holidays, and Floating Holidays
• Tuition Reimbursement

About the company

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