PVQA Manager ( Pharmacovigilance Quality Assurance Manager )

Work Mode: On-site (Work from Office)

Key Responsibilities

• Conduct independent quality reviews of Individual Case Safety Reports (ICSRs) with a strong understanding of the end-to-end ICSR process
• Oversee the quality review of aggregate safety reports (preferred but not mandatory)
• Develop and maintain the lifecycle of Standard Operating Procedures (SOPs)
• Manage the change control system and handle deviations or non-conformances, including investigations, root cause analysis, implementation of corrective and preventive actions, and monitoring of effectiveness
• Identify and implement process improvements and best practices in PV quality assurance methodologies
• Maintain and update training matrices and ensure delivery of relevant and timely training programs
• Prepare for audits and inspections by coordinating data requests and communication with internal teams and external authorities
• Address audit findings and implement corrective and preventive actions as required
• Monitor compliance and risk across multiple projects at defined intervals
• Conduct regular quality review meetings and ensure documentation and follow-up on action points

Desired Skills & Attributes:

• Good understanding of PV quality systems, compliance processes, and regulatory expectations
• Ability to independently manage quality review activities and provide constructive feedback
• Strong problem-solving skills with a practical approach to handling deviations and driving improvements
• Good communication skills with experience in coordinating across multiple teams
• Comfortable working in a fast-paced environment with shifting priorities

Preferred Background :

• Experience in pharmacovigilance quality assurance with exposure to both pharmaceutical companies and service-based organizations
• Prior experience in pharmacovigilance operations is an advantage.

Educational Qualifications :

• Bachelors or masters degree in pharmacy or a related field.
• Experience:10 to 15 years of relevant experience in pharmacovigilance quality assurance
• Previous experience in leading or mentoring teams is preferred