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Post : Manager, Pharmacovigilance Compliance and Quality
Job Description :
Role & Responsibilities :
The Manager, Pharmacovigilance Compliance and Quality Oversight, is primarily responsible for the operational aspects of the Compliance Strategy and Analytics (CSA), Individual Case Safety Report (ICSR), core End of Line Quality (EOLQ) review process, investigating and documenting late ICSR, Aggregate Report and ESI/SSI submissions to Health Authorities, monitoring the timely exchange of ICSRs with Alliance Partners and, monitoring inbound ICSR performance from multiple sources. The Manager is responsible for seeing the generation, quality review, and distribution of compliance and quality metrics and trending activities. They will participate in audits and inspections as Subject Matter Expert (SME) for PV Compliance and Quality activities, performing User Acceptance Testing (UAT) of reports, and visualizations, as necessary. They must participate in and/or lead cross-functional compliance, quality, and process improvement initiatives while providing input into corrective/preventative actions and effectiveness measures for Corrective and Preventative Action plans (CAPA), as appropriate. The manager will also be responsible for resolving complex issues related to day-to-day activities independently, determining when to escalate issues to senior management, and oversight of vendor resources performing services on behalf of CSA.
Roles and Responsibilities
• Operational Performance Analysis
- Manages the PV Quality Review Process
- Coordinates with Compliance Senior Management and QPPV to ensure consistent fulfillment of the global PV obligations
- Partners with the operations teams, global case processing centers, and Local Operating Companies/Local Safety Officers to develop strategies for quality and compliance improvements
- Partners with internal stakeholders to monitor vendor quality
- Investigates and documents scores below quality thresholds
- Manages responses to Health Authority Data Quality Reports
• Investigations of Late Health Authority and Alliance Partner Submissions
- Investigates late ICSR, Aggregate Report, ESI/SSI submissions to Health Authorities (HA)
- Documents, monitors, and trends reasons for late submissions and opening Quality Investigations for identified trends
- Monitors Inbound and Outbound PVA compliance to Alliance Partners (AP) and documents reasons for lateness where threshold is met, or late exchange causes late Health Authority Submissions to Health Authorities
- Analyzes trends for reasons of late submissions to HA or AP
- Opens Quality Investigations when trend is identified
- Works with key stakeholders to ensure robust corrective/preventative and effectiveness checks are implemented
- Monitors ICSR inbound performance from multiple sources to drive high HA compliance and opening QI when trends are identified
• Generation and distribution of Pharmacovigilance Compliance and Quality Metrics
- Generates, reviews, and distributes compliance and quality metrics for the oversight of the Quality Management System
- Collaborates with key stakeholders to ensure metrics meet oversight needs
- Develops, reviews, implements, and/or validates new metrics presentations, visualizations, and reports
Candidate Profile
Position Requirements :
• Minimum of bachelor's Degree in a relevant discipline (Business, Science, Medical, Operations, etc.) with 8 years of pharmaceutical industry experience or advanced academic degree with 5 years of pharmaceutical industry experience
• Minimum of 5 years of experience in PV and/or PV compliance monitoring
• Knowledge of GxP requirements
• Experience with safety processing, clinical study safety reporting, PV, and medical information
• Knowledge of global PV laws and regulations
• Experience in participation, management, or conduct of audits/inspections
• Proficiency in Microsoft Excel and SharePoint
• Problem-solving skills to interpret data & information, analyze, and make recommendations
Preferred Requirements :
• Ability to function in a global matrix environment
• Excellent communication and writing skills
• Ability to lead global work streams, drive teams to make decisions, achieve deliverables and, manage and resolve issues independently
• Understanding of and experience with multi-cultural working
• Ability to evaluate processes and procedures against outcomes to identify methods to improve efficiency, accuracy, and compliance
• Ability to utilize appropriate initiative and autonomy in achieving objectives
• Excellent track record with negotiation and collaboration
• Project Management experience with organizing actions and managing team activities
• Experience developing and conducting presentations for different levels of management with the ability to tailor presentations to the appropriate level of detail
Additional Information :
Experience : Minimum of 5 years of experience
Qualification : Bachelor's Degree
Location : Greater Mumbai, India
Industry Type : Pharma
Functional Area : Pharmacovigilance Compliance and Quality
End Date : 20th October, 2022
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