Associate, Drug Safety - Quality, Standards & Training

Why This Role Matters
The Associate, Drug Safety – Quality, Standards & Training ensures the consistent application of pharmacovigilance (PV) standards and quality systems across Azurity Pharmaceuticals. By supporting SOP management, training, audits, and inspection readiness, this role helps maintain regulatory compliance, enhances process reliability, and protects patient safety across the organization’s global operations.

Job Description
This associate-level position, based in Hyderabad, reports to the Manager, Drug Safety Compliance. The role involves supporting drug safety quality systems, coordinating training programs, maintaining SOPs and documentation, and assisting in regulatory inspections and audits. The Associate works closely with cross-functional teams to ensure compliance, process standardization, and continuous improvement within the Global Drug Safety organization.

Key Features of the Role
• Support the administration and maintenance of Drug Safety SOPs, work instructions, and standards.
• Coordinate onboarding and refresher training programs for Drug Safety personnel.
• Track training completion, maintain records, and report compliance metrics.
• Assist with preparation for regulatory inspections and internal/external audits.
• Maintain inspection-ready documentation and training records.
• Partner with Operations, Compliance, Quality, Regulatory Affairs, and Clinical teams to ensure standards are consistently applied.
• Serve as a communication point for quality- and training-related initiatives within Drug Safety.
• Support global initiatives requiring standardized processes and training support.

Responsibilities
• Maintain and update Drug Safety SOPs, work instructions, and related documentation.
• Coordinate and support Drug Safety training programs for staff, including compliance tracking.
• Assist in preparing for audits and inspections by organizing relevant documentation.
• Support the implementation and adherence to quality standards and procedures.
• Facilitate communication between Drug Safety, Compliance, Quality, and other departments.
• Support continuous improvement initiatives and standardized global processes.

Required Qualifications
• 1–3 years of experience in pharmacovigilance, quality, compliance, training, or related pharmaceutical/regulated healthcare roles.
• Experience with quality systems, SOP management, and training coordination preferred.
• Understanding of pharmacovigilance and regulated quality environments.

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

Experience and Skills
• Familiarity with global pharmacovigilance regulations and compliance standards.
• Strong organizational, documentation, and communication skills.
• Ability to work collaboratively across cross-functional teams.
• Attention to detail and commitment to regulatory compliance and quality standards.

Salary Insights
• Compensation as per company standards; details discussed during recruitment.

Company Overview
Azurity Pharmaceuticals is a privately held specialty pharmaceutical company delivering innovative medicines for underserved patients. Its global portfolio spans cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets. Azurity is committed to patient-centric solutions, high-quality products, and inclusive workplace culture.

FAQs
• Who can apply?
Candidates with experience in pharmacovigilance, quality, compliance, or training roles within pharmaceutical or regulated healthcare environments.
• Is this role office-based or remote?
Based in Hyderabad, working within the Drug Safety Compliance team.
• What departments will the Associate collaborate with?
Drug Safety Operations, Compliance, Quality, Regulatory Affairs, and Clinical teams.
• Are audits and inspections part of the role?
Yes, supporting preparation and documentation for internal and regulatory inspections is required.

Application Tips
• Highlight experience in pharmacovigilance, quality systems, and SOP management.
• Emphasize prior training coordination or compliance-related work.
• Demonstrate familiarity with regulatory requirements and inspection readiness.
• Showcase strong organizational and communication skills.
• Include examples of collaboration with cross-functional teams and continuous improvement initiatives.