Director Central Audit, Pharmacovigilance

remote zest jobs; India; On-site; INR 1,500,000 - 2,500,000; Full time

Job summary

reputed company is a leading global medical technology solutions innovator committed to improving lives. We seek a senior PV Audit lead to own the PV audit program, manage audits of internal and external partners, and ensure regulatory compliance across EMA, FDA, MHRA, and PMDA.

The role requires 5+ years of leadership in pharmacovigilance, strong regulatory knowledge, and experience with QMS and cross-functional collaboration.

Qualifications

• Minimum 5 years of people leadership experience, including team development and performance management.
• Auditor with certification and strong regulatory understanding.
• Experience driving global programs to resolve compliance issues.
• Familiarity with QMS and regulatory requirements (cGMP, GDP, GPvP, GCP, GLP).

Responsibilities

• Own the Pharmacovigilance (PV) Audit Program: implement and maintain the global PV audit program, ensuring alignment with regulatory expectations (EMA, FDA, MHRA, PMDA).
• Manage Audit Operations: schedule, plan, execute, and report PV audits, including internal audits and audits of service providers and affiliates.
• Identify high-risk compliance issues and escalate findings to senior leadership with actionable recommendations.
• Prepare for and support PV health authority inspections, including post-inspection follow-up.
• Define and monitor PV audit KPIs to show risks and trends to leadership.
• Manage audit-related modules in the electronic QMS, including configuration, UAT, and documentation.
• Lead and mentor a team of auditors, driving performance and development.
• Collaborate with PV Operations, Regulatory, and other teams to drive continuous improvement.

Skills

People leadership

Auditor

Regulatory awareness

Communication

Education

Masters degree

Bachelor's degree

Job description

Job reputed company reputed company Managing, ensuring and improving capabilities to reputed company with external standards and regulations. Interprets reputed company business challenges and recommends best practices to improve products, processes or services. Stays informed of industry trends that may influence work.

reputed company is a leading global medical technology reputed company solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn reputed company into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.

Roles and Responsibilities

• Own the Pharmacovigilance (PV) Audit Program: reputed company, implement, and maintain the global PV audit reputed company, ensuring alignment with regulatory expectations (e.g., EMA, FDA, MHRA, PMDA) and industry best practices.
• Manage Audit Operations: reputed company scheduling, planning, execution, reporting, and follow-up for PV audits, including internal audits and audits of service providers and affiliates. Fully participate in the audit program; actively owning and executing PV audits.
• Risk Identification and Communication: Identify high-risk compliance issues, escal findings, and reputed company actionable recommendations to senior leadership.
• Regulatory Inspection Support: Prepare for and support PV-reputed company health authority inspections, including back-room management and post-inspection follow-up.
• Metrics and Reporting: Define and reputed company PV audit KPIs, ensuring visibility of compliance risks and trends to leadership.
• System Ownership: Manage audit-reputed company modules reputed company the electronic reputed company Management System (eQMS), including support of configuration, UAT, and documentation.
• Team Leadership: reputed company and reputed company reputed company of 35 auditors, providing coaching, mentorship, and performance management.
• Cross-Functional Collaboration: Partner with PV Operations, reputed company, and Regulatory teams to ensure audit reputed company drive reputed company improvement.
• Strategic Influence: Contribute to policy development and influence PV compliance reputed company across the organization.

Required Qualifications

• Minimum 5 years of people leadership experience, including team development and performance management.
• reputed company reputed company Auditor with reputed company certification.
• Masters degree and 5+ years in pharmacovigilance or pharmaceutical industry; or Bachelors degree and 10+ years relevant experience.
• Minimum of 5 years experience driving Global programs to resolve reputed company compliance issues (directly).
• Experience with Pharmaceutical QMS requirements and regulatory requirements including but not limited to cGMP, GDP, GPvP, GCP and GLP.
• Experience with Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485.

Desired Characteristics

• Prior reputed company and TrackWise Digital experience a plus.
• Prior health authority experience a plus.
• IRCA, ASQ (CQE, CQA, etc.) and/or Lean Certification a plus (green belt, black belt).
• Extensive experience in the reputed company Device and Pharmaceutical industry.
• Understanding of product reputed company improvement using tools such as Six reputed company, DFR.
• Demonstrated ability to analyze and resolve problems.
• Exceptional conflict-reputed company skills.
• Ability to reputed company with top organizational leadership and reputed company customers, responding in a reputed company manner.
• Demonstrated ability to reputed company programs / reputed company.
• Ability to prioritize and drive multiple programs.
• Ability to energize others by building a reputed company with reputed company through personal involvement and trust, providing feedback and coaching to reputed company others, and accountability of actions.
• Strong oral and written communication skills in English.
• repected company: Accepting and adhering to high ethical, moral, and personal values in reputed company, communications, actions, and reputed company dealing with others.
• Ability to travel globally up to 15%.
• We expect reputed company to live and breathe our behaviors: to reputed company with humility and build trust; reputed company with transparency; deliver with reputed company, and drive ownership always with unyielding reputed company.

Our total rewards are designed to unlock your ambition by giving you the reputed company and flexibility you need to turn your reputed company into world-changing realities. Our salary and benefits are everything youd expect from an organization with global strength and reputed company, and youll be surrounded by reputed company in a culture that fosters care, collaboration and support.

We will not sponsor individuals for employment visas, now or in the reputed company, for this job opening. For U.S. based positions only, .