The Associate Director, Patient Safety & Pharmacovigilance (PSPV) Compliance, Standards, and Training, is responsible for refining/ improving, maintaining, and executing the PSPV quality and compliance framework for in-development and marketed products. The role serves as an advisor for PSPV compliance, standards, and training matters and cross-functional leader across PSPV, Quality Assurance, Clinical, Legal, Commercial, Medical Affairs, and other R&D functions, providing risk-based recommendations, resolving complex issues, and escalating matters requiring Director-level decisions. The position leads significant cross-functional initiatives and provides leadership, coaching, and performance oversight for assigned staff and project teams. Additional responsibilities may be assigned based on organizational needs and business priorities.
Responsibilities:- Refine and maintain the PSPV Quality Management System (QMS)
- Serve as a subject matter expert and advisor on PSPV compliance, standards, and training matters; provide risk-based recommendations to PSPV and cross-functional leaders and escalate matters with significant regulatory, patient safety, or business impact
- Lead significant or complex PSPV investigations and quality issues, including governance of root cause analysis, corrective and preventive action (CAPA) plans, implementation, and effectiveness monitoring; ensure issues are appropriately documented and escalated
- Lead and manage compliance monitoring activities, including evaluating trends and timely remediation
- Lead complex, cross-functional programs within Compliance, Standards, and Training, including governance, risk management, decision-making, and communication of outcomes to senior stakeholders
- Serve in a leadership during regulatory inspections and audits, including readiness planning, evidence strategy, interview preparation, response development, and remediation governance
- Provide governance and oversight on the development, maintenance, and continuous improvement of processes for PSPV procedures and training materials
- Assess the impact of changes to global pharmacovigilance requirements on PSPV processes, standards, systems, and training; recommend implementation strategies and direct assigned change activities
- Lead assigned role-based PSPV training programs, including training strategy, curricula, onboarding, periodic training and retraining
- Lead, coach, and develop assigned employees and project teams; set objectives, monitor performance, and build organizational capability and succession readiness within the function
- Provide compliance oversight and risk-based governance of PSPV vendors and vendor-related quality issues
- Provide compliance oversight of ICSR and aggregate reporting processes, including escalation of compliance risks
- Lead continuous improvement of processes arising from gap assessments for PSPV procedures and training material; recommend priorities and governance actions; and oversee implementation of significant or cross-functional improvements
- Provide governance and oversight of PSMF maintenance activities
- Lead assigned PSPV launch-readiness activities
- Assess impact on assigned systems and change activities
- Act on behalf of the Director for assigned forums or initiatives, within delegated authority, and ensure decisions, risks, and matters requiring broader strategic direction are communicated and escalated appropriately
Preferred Skills, Qualifications and Technical Proficiencies:- Extensive knowledge of and demonstrated experience with Good Pharmacovigilance Practices (GVP)
- Knowledge of and experience with Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Distribution Practice (GDP) are highly desirable
- Ability to work across geographic boundaries, with strong leadership skills and the ability to inspire colleagues
- Sound judgment and decision-making skills
- Ability to influence and motivate others without direct authority
- Proven people-leadership and performance-management experience
- Action- and results-oriented approach
- Project management skills are preferred
Preferred Education and Experience:- Bachelor's degree in healthcare, life sciences, or a related discipline is required; a master's degree in management, leadership, or a scientific discipline is a plus
- Minimum of 8 years of experience in the pharmaceutical industry with 3+ years of progressively responsible experience in pharmacovigilance compliance, standards, training, quality systems, or a closely related area
- Experience in a leadership role during regulatory inspections or audits, including readiness planning, is required; experience with response development is preferred
The pay range that the Company reasonably expects to pay for this headquarters-based position is $183,500 - $242,800; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.
Applicants must be currently authorized to work in the United States on a full-time basis.
