Executive Director, Global Patient Safety Quality and Compliance - Pharmacovigilance

Responsibilities

• Oversight of the Pharmacovigilance Quality Management System (PV-QMS)
• PV training strategy
• PV controlled documentation
• Inspection and audit management
• Ensuring inspection readiness
• Corrective Action Preventive Action (CAPA) management
• Quality Assurance (QA)
• Maintenance of Good Clinical Practice (GCP) and Good Pharmacovigilance Practices (GVP)
• Development and implementation of the pharmacovigilance system
• Strategic development of quality initiatives
• Supporting a quality-focused culture
• Ensuring compliance with global pharmacovigivalnce regulations and standards
• Leading the GPS response to regulatory inquiries and inspections
• Developing and maintaining a pharmacovigilance quality system in line with global regulations
• Partnering with pharmacovigilance systems personnel in the development and implementation of advanced safety data analytics
• Building, mentoring, and leading a high-performing global pharmacovigilance team
• Promoting continuous professional development and ensuring the team is equipped with the latest knowledge and skills in pharmacovigilance

Qualifications

• RN or Bachelor’s degree in biological sciences or health related field
• Advanced degree in Pharmacy, or a related field (PharmD, PhD: preferred)
• Minimum of 15+ years of experience in pharmacovigilance or related field within the pharmaceutical or biotechnology industry
• Minimum of 10+ years of project and line management experience; strong people management skills, willingness to help others, and ability to deal with ambiguity
• Proven track record of leadership in global pharmacovigilance environments
• Experience and success in interacting with Regulatory Authorities (i.e. FDA, EMA)
• In-depth knowledge of global pharmacovigilance regulations and guidelines (i.e. ICH, GxP)
• Strong analytical and strategic thinking, problem-solving, and decision-making skills
• Excellent communication, collaboration, and team management abilities, enabling exertion of strong and successful influence of senior executives as well as strong external representation for the company
• Demonstrated technical expertise in QA/QC
• Outstanding emotional intelligence
• Proven ability to lead and develop people