Pharmaceutical Compliance Specialist

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Assist with the REMS Call Center program to ensure compliance with FDA-mandated requirements and objectives.

• Perform investigations into potential non-compliance within REMS programs.

• Oversee prompt, thorough, confidential, and objective investigations in alignment with Syneos Health and REMS Program standards.

• Execute assigned program compliance responsibilities, which include re-education of stakeholders, documentation of non-compliant incidents, reviewing alerts/reminders, and following up with healthcare providers/pharmacies.

• Coordinate and ensure timely implementation of corrective actions in collaboration with stakeholders.

• Deliver training and education to contracted SPs and/or SDs regarding program processes and data requirements.

• Participate in auditing and/or monitoring activities for the REMS program.

• Identify, investigate, address, and document/track potential non-compliance with REMS program standards.

⛳️ Requirements

• Bachelor’s Degree is mandatory.

• Experience with Risk Evaluation and Mitigation Strategy (REMS) is necessary.

• Familiarity with call center operations and procedures is required.

• A minimum of one year of experience in the pharmaceutical or healthcare sector, emphasizing compliance, is essential.

• Proficient in telephone and/or customer service skills and etiquette.

• Strong computer and data entry abilities; capable of quickly learning new systems and programs.

• Ability to work collaboratively within a team and maintain a positive demeanor.

• Clear and effective communication skills, both written and verbal, are essential.

• Capability to multitask, prioritize daily responsibilities, and meet deadlines.

• Excellent analytical, problem-solving, and organizational skills are required.

• Experience in a fast-paced and high-pressure environment.

• Ability to maintain confidentiality concerning compliance and company information and activities.

• Current knowledge of rules, regulations, and industry guidelines pertaining to healthcare compliance.

• Effective communication with Engagement Center representatives, internal departments, clients, and management is crucial.

• Proficiency in Microsoft Word, Excel, PowerPoint, Outlook, or similar email programs.

• Experienced with investigation databases and case management systems and tools.

🏝️ Benefits

• Health benefits including Medical, Dental, and Vision coverage.

• Company-matched 401k.

• Flexible paid time off (PTO).

• Sick leave.

• Competitive compensation package.

• Support, resources, and autonomy.

• Opportunities for development and advancement.

• A diverse, inclusive, and authentic workplace.

• Voluntary COVID-19 vaccination policy.