Drug Safety Reporting Specialist

Description

ABOUT ORSINI

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.

CORE 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.

COMPENSATION & LOCATION

The salary range for this role is $55,000-$58,000, compensation will be determined based on a combination of factors, including skills, experience, and qualifications.

This is a fully remote position but may involve occasional overnight travel, although limited.

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.

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.

Disclaimer: The information written in this job description indicates the general nature and level of work to be performed. This job description is not designed to contain or be interpreted as totally comprehensive of every job duty, responsibility, or qualification required by an employee assigned to this job. While employed in this position, an employee may be required to perform other assignments not listed in this job description.

EXPERIENCE & EDUCATION

• High School Diploma or GED equivalent and at least 1 year of relevant work experience required.

KNOWLEDGE

• Prior experience with adverse event and product quality complaint reporting required.
• Familiarity with pharmacy industry and/or previous pharmacy experience, preferred.

SKILLS

• Ability to prioritize, multi-task, and manage very time sensitive tasks effectively to meet strict deadlines required.
• Ability to gather information from medical records and patient notes and enter into adverse event and product complaint forms that meet manufacturer requirements required.
• Proficiency with Microsoft products, including Word, Excel, and Power Point, as well as Adobe Acrobat.
• High degree of accuracy 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.

EMPLOYEE BENEFITS

We offer a comprehensive benefits package designed to support your health, financial security, and overall well-being:

• Medical Coverage, Dental, and Vision Coverage
• 401(k) with employer match
• Accident and Critical Illness coverage
• Company-paid life insurance options
• Generous PTO, paid holidays, and floating holidays
• Tuition reimbursement program.

Equal Employment Opportunity

Orsini Rare Disease Pharmacy Solutions is committed to the principle of Equal Employment Opportunity for all employees and applicants. It is our policy to ensure that both current and prospective employees are afforded equal employment opportunity without consideration of race, religious creed, color, national origin, nationality, ancestry, age, sex, marital status, sexual orientation, or present or past disability (unless the nature and extent of the disability precludes performance of the essential functions of the job with or without a reasonable accommodation) in accordance with local, state and federal laws.

Americans with Disabilities Act

Applicants as well as employees who are or become disabled must be able to perform the essential job functions either unaided or with reasonable accommodation. The organization shall determine reasonable accommodation on a case-by-case basis in accordance with applicable law.

Salary : $55,000 - $58,000