Associate, Drug Safety – Quality, Standards & Training Full Time NEW

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 Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity’s success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization.

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.

By applying for this role, you confirm that you are mentally and physically capable of fulfilling the job responsibilities detailed in the job description without any restrictions. If you have any concerns or even the slightest disability that may affect your ability to perform the job, please inform HR in advance.