QA Manager — Pharmacovigilance

TheClinixAI; Hyderabad; Hybrid; INR 1,500,000 - 2,700,000; Full time

Job summary

TheClinixAI is seeking a QA Manager — Pharmacovigilance to lead the quality framework for PV operations, ensuring audit readiness and CAPA effectiveness from Hyderabad, with flexibility for remote work part of the week.

The role requires 5–8 years in PV quality/QC, solid GVP knowledge and strong stakeholder communication to drive a mature quality culture across PV, QC and leadership teams.

Qualifications

• 5–8 years of PV quality, QA or drug safety experience including leadership.
• Strong knowledge of PV processes, GVP, ICSR quality and audits.
• Experience with CAPA, deviations, root-cause analysis and inspection readiness.

Responsibilities

• Own and maintain the PV quality assurance framework, quality plan and risk-based oversight.
• Monitor quality metrics, trends, deviations and operational risk.
• Lead or support internal and client audits and inspection readiness activities.
• Oversee CAPA investigations, root-cause analysis and closure quality.
• Review and approve quality procedures, work instructions and controlled docs.
• Partner with PV operations and QC to improve case quality and compliance.
• Establish calibration and quality-review standards across teams.
• Prepare quality dashboards and management reports with recommendations.
• Support vendor/partner quality oversight where applicable.
• Foster data integrity and continuous improvement.

Skills

PV QA leadership

Quality metrics

Audits & CAPA

GVP knowledge

Data integrity

Stakeholder management

Documentation

Education

Bachelor/Master in Pharmacy or Life Sciences

Tools

GxP software

Job description

QA Manager — Pharmacovigilance

Hyderabad / Remote · 5–8 years experience · Quality Assurance

About the role

Lead the quality framework supporting pharmacovigilance operations, with responsibility for quality oversight, metrics, audits, CAPA, process improvement and inspection readiness. The role partners with PV operations, QC, training and leadership to build a mature quality culture.

Key responsibilities

• Own and maintain the PV quality assurance framework, quality plan and risk-based oversight approach.
• Monitor quality metrics, trends, deviations, recurring findings and operational risk.
• Lead or support internal audits, client audits and inspection-readiness activities.
• Oversee CAPA investigations, root-cause analysis, effectiveness checks and closure quality.
• Review and approve quality procedures, work instructions, forms and controlled documentation.
• Partner with PV operations and QC teams to improve case quality, literature quality and compliance.
• Establish calibration and quality-review standards and ensure consistent application.
• Prepare quality dashboards and management reports with actionable recommendations.
• Support vendor or partner quality oversight where applicable.
• Promote data integrity, documentation discipline and continuous improvement.

Required qualifications

• Bachelor's or master's degree in Pharmacy, Life Sciences, Medicine or related discipline.
• 5–8 years of relevant PV quality, QA, QC or drug safety experience, including leadership responsibility.
• Strong knowledge of PV processes, GVP principles, ICSR quality and audit practices.
• Experience with CAPA, deviations, root-cause analysis, quality metrics and inspection readiness.
• Strong stakeholder management and written communication.

Preferred skills

• Experience in client/vendor audits and regulatory inspections.
• Knowledge of validated computerized systems and data integrity principles.
• Experience building QA frameworks for growing PV operations.