Associate, Drug Safety – Quality, Standards & Training
Azurity Pharmaceuticals is seeking an Associate, Drug Safety – Quality, Standards & Training to join its Global Drug Safety organization in Hyderabad, India. This role is integral in maintaining inspection readiness, supporting compliance with global pharmacovigilance regulations, and ensuring consistent execution of drug safety processes through effective documentation and training. The position reports to the Manager, Drug Safety Compliance and collaborates closely with Drug Safety Operations, Compliance, Quality, and other cross-functional teams.
Key responsibilities include supporting the maintenance and administration of Drug Safety Standard Operating Procedures (SOPs), work instructions, and standards, including document updates and version control. The role also involves coordinating Drug Safety training programs, such as onboarding and periodic refresher training, tracking training completion, maintaining training records, and supporting the reporting of training compliance metrics. Additionally, the associate will assist in preparing for regulatory inspections and internal and external audits related to pharmacovigilance, as well as organizing and maintaining inspection-ready documentation and training records.
Candidates should have 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 is preferred. A clear understanding of pharmacovigilance and the regulated quality environment is essential. A bachelor's degree in Life Sciences, Healthcare, Quality, Training, or a related field is required.
Azurity Pharmaceuticals offers a collaborative and inclusive work environment, emphasizing professional growth and development. Employees have the opportunity to work on innovative products that meet the needs of underserved patients, contributing to a broad commercial product portfolio and a robust late-stage pipeline. The company values dedication, integrity, and a creative spirit, providing a platform for individuals to thrive and make a meaningful impact in the pharmaceutical industry.