Rems Pharmacovigilance Operations Lead

Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company’s patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit www.azurity.com.

Azurity is seeking a highly motivated REMS Pharmacovigilance Lead to join the Medical Affairs team, in Atlanta, GA. This individual will leverage existing industry knowledge combined with organizational and communication skills to support ongoing drug safety/pharmacovigilance and REMS initiatives while maintaining and prioritizing compliance.

Duties & Responsibilities:

• Manage day-to-day activities of Risk Evaluation and Mitigation Strategies (REMS) program to maintain regulatory compliance
• Liaise with specialty pharmacies to ensure that all REMS requirements and processes are managed and maintained
• Communicates with the Director of Drug Safety about signals and safety trends
• Oversight and management of Risk Evaluation and Mitigation Strategies (REMS) day-to-day activities
• Work cross-functionally to ensure that the reporting process and reporting responsibilities are carried out
• Assess and implement ongoing REMS process and service-related improvements to ensure continuity and patient satisfaction while fostering a positive prescriber experience
• Serve as the liaison with oversight committees
• Ensure that all REMS operations run smoothly and are in compliance with current regulations
• Ensure that Vendor SOPs are maintained, up to date, and are being followed
• Work with REMs external stakeholders to ensure that compliance is maintained

Qualifications:

• Ability to work across multiple therapeutic areas
• Excellent communication and presentation skills
• Degree in Biomedical or healthcare-related specialty (DO, PharmD, NP, RN, MPH)
• Advanced Project Management Skills
• Experience maintaining workflows and Standard Operating Procedures (SOPs)
• Recent Pharmaceutical industry experience with patient services and/or vendor management
• Experience conducting training internally and externally
• Expert knowledge and understanding of REMS Regulations and guidances
• Ability to critically think and overcome challenges in a fast-paced environment
• Rare disease experience is a plus
• Experience supporting inspections specific to REMs programs
• Ability to critically and strategically apply knowledge
• Expert knowledge and proven track record of REMS management and operations
• Experience designing, developing, and implementing continuous improvement and ongoing customer support initiatives
• Ability to work with a high degree of autonomy in a fast-paced environment
• 5+ years of relevant and recent experience in the pharmaceutical industry with at least 3 years of direct experience working with Risk Evaluation and Mitigation Strategies (REMS)