Pharmaceutical Compliance Specialist

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

📋 Description

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

• Carry out investigations related to potential non-compliance in REMS programs.

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

• Execute program compliance tasks, including re-educating stakeholders, documenting non-compliant incidents, reviewing alerts/reminders, and following up with healthcare providers/pharmacies.

• Facilitate corrective actions with stakeholders and guarantee timely execution.

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

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

⛳️ Requirements

• A Bachelor’s Degree is required.

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

• Familiarity with call center operations and processes.

• At least one year of experience in the pharmaceutical or healthcare industry, focusing on compliance.

• Experience in telephone and/or customer service, demonstrating proper etiquette.

• Proficient computer and data entry skills; ability to quickly adapt to new systems and programs.

• Capacity to collaborate with a team while maintaining a positive demeanor.

• Strong written and verbal communication abilities.

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

• Exceptional analytical, problem-solving, and organizational skills.

• Experience thriving in high-pressure and fast-paced environments.

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

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

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

• Proficient in Microsoft Word, Excel, PowerPoint, Outlook, or similar electronic mail applications.

• Skilled in using investigation databases and case management systems and tools.

🏝️ Benefits

• Competitive compensation package.

• Medical, dental, and vision health benefits.

• Company matching 401(k).

• Flexible paid time off (PTO).

• Sick leave.

• A diverse, inclusive, and authentic workplace environment.

• Access to support, resources, and autonomy.

• Opportunities for development and advancement.

• Voluntary COVID-19 vaccination policy; vaccination may be mandated by certain local governments or customers.