Description

This position is responsible for providing best-in-class Safety and Risk Evaluation and Mitigation Strategy (REMS) education to current and prospective prescribers, healthcare professionals (HCPs), and/or representatives of healthcare settings. The Safety Program Advisor will provide educational and operational support to ensure patient safety and REMS program compliance.

Responsibilities Include:

Educational Support:

• Provide REMS education to prescribers, HCPs, Pharmacies, Healthcare Settings, and Authorized Representatives.
• Offer REMS education and portal training.
• Respond to requests for REMS information.
• Communicate with certified stakeholders to ensure prevention of undue burden or access barriers.
• Deliver REMS training, best practices, and operational excellence proposals to cross-functional partners within the Therapeutic Area(s).

Operational and Stakeholder Support:

• Support required audits or Corrective and Preventive Actions (CAPA), including operational support for healthcare providers, pharmacies, and all other stakeholders, as needed.
• Prevent undue burden or access barriers for certified external stakeholders through communication, and internal alignment.
• Provide best practices and implementation insights to help stakeholders improve their REMS processes and procedures as well as streamline workflow when possible.
• Collaborate with field medical and commercial partners to provide support with REMS inquiries, training, or operational needs.
• Actively seek stakeholder and business partner feedback about our REMS program, REMS Call Center, materials, and technologies.
• Communicate availability and importance of REMS surveys used in regulatory reporting.
• Identify enhancements that would reduce the administrative burden for REMS stakeholders.
• Analyze all stakeholder feedback, address rapidly and propose solutions.

Additional Responsibilities:

• Record all customer interactions utilizing the internal database and the Safety Advisor team reporting tracker.
• Maintain a thorough understanding of FDA (Food and Drug Administration) REMS regulations and industry trends regarding the implementation of REMS programs.
• Ensure a comprehensive knowledge of REMS departmental operations, including all SOPs (Standard Operating Procedure), work practices and technologies.
• Run and maintain reports regarding activities, outcomes, and trends.
• Provide scheduled and ad-hoc reports to the leadership team as required.
• Support newer members of the Safety Program Advisor team with mentoring and coaching.
• Assist with oversight and handling of the Safety Program Advisor mailbox.
• Complete all company and program training.
• Other Responsibilities as Assigned

Required Qualifications:

• Bachelor’s degree or equivalent degree, required
• Conversational knowledge of healthcare environment with business acumen
• Excellent written, verbal, and interpersonal communication skills
• Familiarity with web-conferencing tools, Excel, and Power Point
• Creative thinker and engaging communicator
• Strong analytical and problem-solving skills
• Strong willingness to collaborate with internal and external stakeholders
• Confidentiality and integrity are required
• Strong work ethic
• Flexible, team member with positive attitude, friendly demeanor, ability to prioritize projects and balance competing priorities
• Up to 10% travel required

Preferred Qualifications:

• 2+ years of Risk Evaluation Mitigation Strategy (REMS) experience preferred
• Pharmaceutical Industry or Clinical Research Organization (CRO) experience preferred
• Pharmacy or nursing degree, preferred
• Audit experience preferred

At Syneos Health, we are dedicated to building a diverse, inclusive and authentic workplace. If your past experience doesn’t align perfectly, we encourage you to apply anyway. At times, we will consider transferable skills from previous roles. We also encourage you to join our Talent Network to stay connected to additional career opportunities.

Why Syneos Health? Here, the work is challenging, and the pace is exhilarating. By joining one of our commercial teams, you’re empowered to succeed with the support, resources, and autonomy that you need. The diversification and breadth of our new and existing partnerships create a multitude of career paths and employment opportunities. Syneos Health has launched more sales teams in the last 5 years across all major therapeutic areas than the top 25 pharma companies combined. Join our game-changing, global company dedicated to creating better, smarter, faster ways to get biopharmaceutical therapies to patients. Experience the thrill of knowing that your everyday efforts are contributing to improving patients’ lives around the world. 

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

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.