Quality Assurance and Pharmacovigilance Associate

Responsibilities

• Support pharmacovigilance and quality processes in accordance with company procedures and regulatory requirements.
• Review, process, and maintain safety and quality-related documentation, ensuring accuracy and completeness.
• Monitor, document, and escalate product complaints, adverse events, deviations, and other quality-related incidents as required.
• Assist with investigations, root cause analysis, corrective and preventive actions (CAPAs), and follow-up activities.
• Maintain accurate records and data within relevant quality and safety management systems.
• Collaborate with cross-functional stakeholders, including regulatory affairs, medical affairs, quality assurance, and operations teams.
• Support audits, inspections, and compliance activities, including document preparation and follow-up actions.
• Ensure adherence to applicable regulations, guidelines, standard operating procedures, and quality standards.
• Respond to internal and external inquiries related to quality and product safety processes.