Brief team/department description:

Azurity Pharmaceuticals is seeking an Associate, Drug Safety – Quality, Standards & Training to support drug safety quality systems, standards, audits, and training activities within the Global Drug Safety organization. This role is integral in maintaining inspection readiness, supporting compliance with global pharmacovigilance (PV) regulations, and enabling consistent execution of drug safety processes through effective documentation and training.

Reporting to the Manager, Drug Safety Compliance this associate-level role will work closely with Drug Safety Operations, Compliance, Quality, and cross-functional partners to support SOP management, training coordination, and continuous improvement initiatives.

Principle Responsibilities:

• Support the maintenance and administration of Drug Safety SOPs, work instructions, and standards, including document updates and version control.
• Support coordination of Drug Safety training programs, including onboarding and periodic refresher training.
• Track training completion, maintain training records, and support reporting of training compliance metrics.
• Support preparation for regulatory inspections internal and external audits related to pharmacovigilance.
• Assist with organization and maintenance of inspection-ready documentation and training records.
• Partner with Drug Safety Operations, Compliance, Quality, Regulatory Affairs, and Clinical teams to support consistent application of standards and training requirements.
• Serve as a point of coordination for quality- and training-related communications within Drug Safety.
• Support global Drug Safety initiatives that require standardized processes or training support.

Qualifications and Education Requirements

• 1–3 years of experience in pharmacovigilance, quality, compliance, training, or related roles within pharmaceutical, biotech, or regulated healthcare environments.
• Experience supporting quality systems, SOPs, and/or training coordination preferred
• Must have a clear understanding of pharmacovigilance and regulated quality environment.

Education

• Bachelor’s degree required in Life Sciences, Healthcare, Quality, Training, or related field.

Brief team/department description:

The Manager, Promotional Material Review Committee, is responsible for managing and supporting the end-to-end operations of the Promotional Review Committee (PRC/MRC). This role is responsible for ensuring promotional materials are reviewed efficiently, consistently, and in compliance with regulatory, medical, and legal requirements while enabling timely commercial execution. Reporting to the Director, Medical Education, this role will partner closely with Medical Affairs, Regulatory, Legal, Compliance, and Commercial teams to drive operational excellence, governance, and inspection readiness across promotional review processes.

Principle Responsibilities:

• Manage day-to-day operations of the Promotional Material Review Committee (PRC/MRC), including scheduling, agenda management, and documentation.
• Coordinate review of promotional materials across channels (e.g., HCP, DTC, digital, print, training materials).
• Ensure clear communication of review outcomes, required revisions, and final approvals to stakeholders.
• Translate complex clinical and scientific data into clear, balanced, and compliant medical content for internal and external audiences.
• Support product launches and lifecycle management through review and creation of foundational medical materials.
• Partner with PMRC/SRC stakeholders to facilitate timely review and approval of materials.
• Collaborate closely with Medical Affairs, Regulatory Affairs, Legal, Compliance, Commercial, and Field Medical teams.
• Serve as a medical content subject-matter partner while maintaining appropriate separation between promotional and non-promotional activities.
• Identify opportunities to enhance content quality, efficiency, and alignment with evolving best practices.

Qualifications and Education Requirements

• 5+ years of experience in promotional review, regulatory affairs, medical affairs operations, or compliance within pharmaceutical or biotech organizations.
• Bachelor’s degree required; advanced degree (PharmD, PhD, MD, or MS) in life sciences or related field preferred.
• Experience supporting or managing Promotional Review Committees (PRC/MRC) strongly preferred.
• Familiarity with FDA promotional regulations, OPDP guidance, and advertising/promotion standards.