Job Description

Job Summary

Global drug safety and pharmacovigilance physician with expertise in: drug safety, risk management, safety surveillance, adverse event management, benefit-risk assessment, and PV compliance in the biotechnology industry.

Provides strategic leadership, management and oversight of case management, operational processes, the quality management system, compliance operations and monitoring, and safety systems for the PV Department. In addition, this role oversees case management and related operational activities. They also ensure that all activities are consistent with global regulatory requirements and the company's operating processes, procedures, regulatory, and legislative requirements.

Responsibilities

• Lead the PV group - team of 4
• Responsible for leading and executing the strategy for PV Operations function in compliance with PV regulatory requirements for investigational and marketed compounds
• Oversight and management of case management and ensuring process optimization, case quality, and accurate regulatory reporting
• Direct the handling of adverse events according to national and international regulatory reporting requirements and ensure timely, complete, and accurate submission of Individual Case safety reports to regulatory authorities in compliance with regulations.
• Accountable for the oversight of the operational activities with the PV vendors and Service Providers
• Oversight of the safety data management strategy.
• Collaborate with Information Technology on implementation and maintenance of the global safety database and tools for data analytics and signal management
• Oversight for the prioritization, planning & execution of global reports, oversight of custom report development and ad hoc query development.
• Maintain oversight of the PV Quality Management System ensuring that systems and processes meet regulatory standards and ensures patient safety related to use of our products.
• Lead the development and maintenance of KPIs, processes and procedures for the Global Patient Safety function.
• Oversight of the management and maintenance of PV Agreements with PV Business partners.
• Ensure audit and inspection readiness in compliance with departmental processes and regulations
• Oversight of recommendations for corrective and preventive actions and tracking corrective action commitments until closure

Experience Requirements

• 15+ years of PV experience
• GI experience is strong positive, but not an absolute requirement.
• Proven track record in leading and participating in regulatory authority inspections
• Working knowledge of and experience with domestic and international regulatory Adverse Event Reporting requirements.
• Experience in preparing and submitting regulatory reports (e.g., PSURs, DSURs)
• Ability to develop and maintain Risk Management Plans (RMPs)
• Experience in conducting benefit-risk assessments and signal detection
• Experience with pharmacovigilance data systems (Oracle Argus, signal detection, and data analytics tools) experience
• Extensive knowledge of biotechnology/pharmaceutical sector drivers and practices throughout the entire product lifecycle
• Extensive knowledge of US and international pharmacovigilance regulations, with experience in their practical application throughout the entire product lifecycle
• Demonstrates advanced skill and keen insight in gathering, analyzing, and applying key information to solve complex problems
• Demonstrates excellent organizational and planning capabilities by managing time, workload, and resources of a department

Educational Requirements

• Medical Doctor (MD)

Job Tags

Similar Jobs