Summary: Reporting to the Drug Safety Director, the PV Quality Manager is responsible for monitoring and assessing Drug Safety procedures to assure compliance with global regulatory requirements. This individual is also responsible for ensuring appropriate training for Drug Safety personnel.
This individual liaises with department management and cross-functional teams throughout the company to optimize department practices. This individual ensures that the department is well positioned for an external PV inspection.
Specific duties (other duties may be assigned)
Monitoring and Assessment responsibilities
• Create, implement and maintain a comprehensive safety metrics program, in conjunction with Drug Safety (DS) Operations, Case Management and SERMs (Safety Evaluation and Risk Management) to monitor compliance, timeliness, data quality, adherence to regulatory guidelines, contractual agreements with global partners, and internal policies and procedures
• Implement a quality management team in PV
• Assess trends, identify opportunities for process improvements, and recommend revisions to controlled documents, training issues/opportunities, and individual performance issues
• Work with DS Case Management and the Regulatory Affairs teams to assess current processes and submission compliance metrics to business partners, third parties, internal stakeholders, and regulatory authorities to identify root causes for late submissions and other opportunities for improvement
• Prepare routine status reports for departmental Management on above metrics and compliance programs
Safety Training Responsibilities
• Responsible for all safety-related training on drug safety policies and SOPs within the company to include drug safety database-specific training for all system users (both internal and external to the company)
o Coordinates development of appropriate training materials and delivers training programs/presentations, in conjunction with appropriate internal and external subject matter experts, as appropriate
o Monitor the effectiveness of safety-related training
• Develop and maintain functional-level training matrices for all positions within the department. Assist department managers in monitoring adherence to training requirements and appropriate documentation in individual’s training records
Audit and Inspection Support
• Act as departmental liaison for audit/inspection activities, in close association with Clinical Quality Assurance (QA) group
• Develop, recommend, and track appropriate corrective actions related to audit/inspection findings to ensure adequate documentation and timelines are met
• Bachelor’s degree – preferably in health related field
Experience and Background:
• 5-8 years direct experience in Drug Safety department in small biotech or comparable experience in large pharmaceutical setting; additional industry experience in QA, Clinical Operations or Regulatory Affairs a plus
• Excellent written and spoken English
• Strong communication skills a must
• Demonstrated leadership responsibilities in previous role (s)
• Strong project management skills
• Demonstrated experience in a regulated industry
• Demonstrated experience working cross functional areas with strong negotiation skills
• Strong knowledge of ICH, US & EU regulations and requirements for pharmacovigilance and experience with world-wide safety reporting regulations and guidelines
• Strong knowledge of MedDRA dictionary and medical terminology
• Excellent interpersonal skills, including ability to work effectively cross culturally and cross functionally.
Seattle Genetics is an equal opportunity employer.
Seattle Genetics - 2 years ago