Offer summary

Qualifications:

Prior experience with adverse event and product quality complaint reporting preferred., Proficiency in Microsoft Office Suite and Adobe Acrobat., Excellent written and verbal communication skills with a high degree of accuracy and attention to detail., Familiarity with the pharmacy industry is preferred..

Key responsibilities:

Complete daily adverse event and product quality complaint forms for manufacturer compliance.

Assist in the investigation of adverse events as assigned.

Respond to follow-up inquiries from manufacturers regarding submitted reports.

Assist with reconciliation of adverse events and product complaints on a weekly, monthly, and quarterly basis.

Job description

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 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