Associate Director, Clinical Trial Patient Safety

Role Summary

This position supports the case processing organization to achieve its mission of improving patient lives globally through industry-leading safety and compliance by consistent and accurate delivery of high quality, relevant and timely adverse event information.

Responsibilities

• Directs, influences, implements and communicates case processing and reporting policy and direction for Global Product Safety.
• Evaluates new regulations and guidelines, develops plans and processes for implementation.
• Communicates and coordinates across functional and global boundaries to ensure timely completion of AE cases for regulatory submission.
• Identifies, evaluates, develops and implements Global Product Safety policies, processes and system improvements.
• Manages department budgets and projects future financial and resource needs.
• Identifies and anticipates potential department problems impacting the ability to meet regulatory requirements and business goals, develops and implements methods of improvement and resolution.
• Manages the audit process, prepares responses and develops associated improvement plans (e.g. FDA meetings; responses to warning letters).
• Works cross-divisionally to influence business processes which impact product safety.
• Ensures a positive employee relationship, work expectations and employee accountability.
• Strategically develops responses to employee relationship trends.
• In absence of Associate Director, is responsible for Associate Director duties, including day to day activities.

Qualifications

• Required: Bachelor's degree with related health sciences background; licensed healthcare professional.
• Preferred: RN, BSN, BS, BS Pharm, PharmD or advanced degree.
• Candidates lacking the appropriate degree but with equivalent previous management or leadership experience may be considered.
• Minimum 1 year clinical experience.
• 4 years of pharmacovigilance experience required.
• Global exposure preferred.
• Demonstrated experience in a management capacity required.
• Significant experience leading cross-functional teams on complex projects required.