Quality Assurance Advisor – Patient Safety (PS)
Location: Bangalore, India (Manyata Tech Park)
Work Mode: Hybrid (3 days on-site / 2 days remote)
Employment Type: Full-time, Permanent
Experience Required: 3–7 years
Work Hours: 9:00 AM–6:00 PM IST or 2:00 PM–11:00 PM IST (based on business needs)
Career Level: Individual Contributor
A leading global biopharmaceutical organization is seeking a Quality Assurance Advisor – Patient Safety (PS) to strengthen its Global Business Services (GBS) operations in India. This role plays a critical part in ensuring high-quality pharmacovigilance and patient safety processes aligned with global regulatory standards.
The position contributes directly to global patient safety objectives by providing independent quality oversight, driving inspection readiness, and supporting continuous improvement across pharmacovigilance systems. This is an excellent opportunity for experienced QA professionals to work in a highly collaborative, global environment focused on patient welfare and regulatory excellence.
Patient Safety Quality & Compliance
Provide end-to-end quality oversight for Patient Safety (PS) processes in alignment with GVP, ICH, local regulations, and internal quality standards.
Maintain and enhance the Patient Safety Quality Management System (QMS), including SOPs, Work Instructions, training frameworks, governance processes, and quality metrics.
Lead the complete SOP lifecycle, including authoring, review, approval, version control, periodic review, and archival.
Quality Management & Continuous Improvement
Analyze KPIs and quality metrics to identify trends, risks, and opportunities for continuous improvement.
Plan and execute risk-based internal assessments and QA reviews to ensure inspection and audit readiness.
Lead investigations related to deviations, non-conformances, and quality issues, including root cause analysis and CAPA management.
Audit, Inspection & Risk Management
Support regulatory inspections and audits, acting as a subject matter expert for Patient Safety QMS processes.
Establish and manage formal change control processes, including impact assessment, risk evaluation, and effectiveness checks.
Monitor risk assessments and ensure appropriate mitigation actions are implemented and sustained.
Stakeholder Collaboration & Training
Partner with global and regional stakeholders across Patient Safety, R&D, Regulatory, Medical Affairs, and Global Business Services.
Support and deliver training programs related to compliance, inspection readiness, and quality performance.
Contribute to the optimization of global patient safety systems, tools, and automation initiatives.
Education
Bachelor’s degree in Life Sciences or a related discipline
Experience
3 to 7 years of experience in GxP Quality Assurance within the pharmaceutical, biotechnology, or life sciences industry
Hands-on experience with Veeva Vault QMS
Strong exposure to Patient Safety, Pharmacovigilance, or related quality systems
Core Skills
Quality system expertise including change management, deviation management, CAPA, audit management, and data integrity
Knowledge of global pharmacovigilance regulations for marketed and investigational products
Strong analytical, problem-solving, and stakeholder communication skills
Ability to manage multiple priorities in a fast-paced, global environment
Experience with pharmacovigilance operations, adverse event reporting, and safety databases (e.g., Argus)
Understanding of clinical research and its interface with PV systems
Experience working in a highly matrixed, multicultural global organization
This role offers the chance to contribute to global patient safety initiatives while working in a collaborative, innovation-driven environment. You will be part of a growing global hub focused on quality excellence, regulatory compliance, and continuous improvement—directly impacting patient safety worldwide.
Equal Opportunity Statement
The organization is an equal opportunity employer and is committed to fostering an inclusive and diverse workplace. All qualified applicants will be considered without regard to race, color, religion, gender, age, disability, sexual orientation, gender identity, or any other status protected by applicable laws.
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