Virtual Pharmaceutical Compliance Specialist

Updated: Yesterday
Location: Raleigh, NC, United States
Job :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.

• 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.

• Bachelor’s Degree required

• 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

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