Virtual Pharmaceutical Compliance Specialist

Syneos Health; Raleigh (NC); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Health benefits (Medical, Dental, Vis

Company 401k match

PTO and sick time

Vaccination policy

Job summary

Syneos Health in Raleigh, NC, is seeking a Virtual Pharmaceutical Compliance Specialist to identify and address noncompliance within REMS programs. You will document investigations and coordinate corrective actions across stakeholders.

The role requires a Bachelor’s degree with experience in REMS and pharmaceutical compliance, plus strong communication and data-entry skills for fast-paced environments.

Qualifications

• Bachelor’s degree required.
• Experience with REMS.
• Knowledge of call center operations.
• 1+ year in pharmaceutical or healthcare compliance.
• Proficient in MS Word, Excel, PowerPoint, Outlook.
• Ability to maintain confidentiality.

Responsibilities

• Support the REMS Call Center program to help ensure FDA mandated requirements/goals are met.
• Conduct investigations of potential non-compliance within REMS programs.
• Manage and ensure prompt, thorough, confidential, and objective investigations in accordance with Syneos Health and the REMS Program requirements.
• Ensure all program compliance duties (including re-education of stakeholders, documentation of non-compliant event, review of alerts/reminders, and healthcare provider/pharmacy follow-up) are completed for the assigned REMS program(s).
• Coordinate corrective actions with stakeholders and follow through to ensure they are implemented in a timely manner.
• Provide training and education to contracted SPs and/or SDs about the program, processes, and data requirements.
• Engage in REMS program auditing and/or monitoring activities.

Skills

REMS

Call center ops

Pharma/Healthcare

Compliance

Communication

Data entry

Teamwork

Confidentiality

MS Office

Investigation tools

Education

Bachelor’s Degree

Job description

Virtual Pharmaceutical Compliance Specialist

Updated: Yesterday
Location: Raleigh, NC, United States
Job ID:18875

You’re a proactive problem-solver who thrives in a fast-paced environment where accuracy, integrity, and compliance matter.

In this role as a Compliance Specialist, you will be responsible for identifying, investigating, addressing, and documenting/tracking any potential noncompliance with the REMS (Risk Evaluation Mitigation Strategies) program requirements.

You will:

• Support the REMS Call Center program to help ensure FDA mandated requirements/goals are met.
• Conduct investigations of potential non-compliance within REMS programs.
• Manage and ensure prompt, thorough, confidential, and objective investigations in accordance with Syneos Health and the REMS Program requirements.
• Ensure all program compliance duties (including re-education of stakeholders, documentation of non-compliant event, review of alerts/reminders, and healthcare provider/pharmacy follow-up) are completed for the assigned REMS program(s).
• Coordinate corrective actions with stakeholders and follow through to ensure they are implemented in a timely manner.
• Provide training and education to contracted SPs and/or SDs about the program, processes, and data requirements.
• Engage in REMS program auditing and/or monitoring activities.

Job Qualifications

Education

• Bachelor’s Degree required

Required Skills

• Experience with Risk Evaluation and Mitigation Strategy (REMS).
• Knowledge of call center operations and processes.
• One or more years of experience in the pharmaceutical or healthcare industry, with emphasis on compliance.
• Knowledge of call center operations and processes.
• Skill in telephone and/or customer service experience and etiquette.
• Efficient computer and data entry skills; ability to learn new systems and programs quickly.
• Ability to work with a team and maintain a positive attitude.
• Ability to communicate clearly and effectively written and verbal.
• Ability to multitask, prioritize day-to-day responsibilities and meet deadlines.
• Excellent analytical, problem-solving, and organizational skills required.
• Experience in high-pressure and fast paced environment
• Ability to maintain confidentiality involving compliance and company information and activities.
• Demonstrate current working knowledge of various rules, regulations, and industry guidance relevant to healthcare compliance.
• Must be able to effectively communicate with Engagement Center representatives, internal departments, clients and management.
• Proficient in Microsoft Word, Excel, PowerPoint, Outlook, or similar electronic mail program.
• Proficient with investigation databases and case management systems and tools.
  

At Syneos Health, we are dedicated to building a diverse, inclusive and authentic workplace.

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Syneos Health companies are affirmative action/equal opportunity employers (Minorities/Females/Veterans/Disabled)

Syneos Health has a voluntary COVID-19 vaccination policy. We strongly encourage all employees to be fully vaccinated. Additionally, certain local governments or Syneos Health customers may have vaccine requirements that apply to some of our employees. These employees are required to submit proof of vaccination to Syneos Health and maintain compliance with these requirements.
At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance.

The benefits for this position will include:

• a competitive compensation package
• Health benefits to include Medical, Dental and Vision
• Company match 401k
• flexible paid time off (PTO) and sick time

Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos Health complies with all applicable federal, state, and municipal paid sick time requirements.

Discover what our more than 25,000 employees already know: work here matters everywhere. We work hard,and smart, all in the name of getting much-needed therapies to thosewho need them most. A career with Syneos Health means your everyday workimprovespatients’ lives around the world. Selecting us as an employer secures acareer inwhich you’re guaranteed to:

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization builtto accelerate customer success. We translate unique clinical, medical affairs and commercialinsights into outcomes to address modern market realities. To learn more visit syneoshealth.com .

Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status,ethnicity, national origin, sex, gender, gender identity, sexual orientation, protectedveteran status, disability or any other legally protected status and will not bediscriminated against. If you are an individual with a disability who requires reasonableaccommodation to complete any part of our application process, including the use of thiswebsite, please contact us at: Email: [emailprotected] One of our staff members willwork with you to provide alternate means to submit your application.