Director, Global PV Management

Position Summary

The Director, Global PV Management is responsible for assessing regional and international pharmacovigilance regulatory requirements and translating them into effective drug safety & pharmacovigilance (DSP) procedures and operational processes. In partnership with DSP team members and other cross-functional key stakeholders, the role monitors regulatory changes in existing markets, assesses PV requirements for entry into new countries, and drives the development and implementation of processes that enable ongoing compliance and operational readiness.

Primary Responsibilities:

• Review and interpret applicable international and regional pharmacovigilance regulatory requirements and assess their impact on company procedures, processes, and outsourced activities.

• Continuously monitor changes to pharmacovigilance requirements in countries where the company operates and coordinate timely assessment and implementation of necessary changes.

• Assess pharmacovigilance requirements for new countries and develop operational readiness plans, including required procedures, responsibilities, and implementation timelines.

• Conduct and document gap assessments comparing regulatory requirements with existing SOPs, work instructions, and operational practices.

• Lead the development and revision of pharmacovigilance procedures, working with Regulatory, Quality, Medical Safety, Risk Management, QST, other cross-functional stakeholders, and service providers, as applicable to ensure requirements are appropriately addressed.

• Collaborate with the Qualified Person for Pharmacovigilance (QPPV) and local country pharmacovigilance responsible persons to assess country-specific requirements, confirm their operational impact, and ensure appropriate incorporation into company procedures and processes.

• Translate regulatory requirements into clear operational steps, defined ownership, and actionable timelines.

• Coordinate procedure review and implementation, and verify that required changes have been incorporated into operational practice.

• Maintain a centralized record of applicable requirements, identified gaps, action owners, implementation status, and supporting documentation.

• Regularly evaluate SOPs and processes to identify compliance gaps, inconsistencies, and opportunities for improvement.

• Partner with the Head of Pharmacovigilance Operations and PV Quality Services & Training to periodically assess adherence to established procedures through targeted, routine process checks. Identify gaps and coordinate appropriate follow-up, including procedure clarification, training, or process improvements.

• Escalate compliance risks and overdue actions to PV leadership and recommend practical solutions.

• Support inspection readiness and responses to findings through regulatory assessments, procedure updates, and supporting evidence.

• Other responsibilities as assigned.

 

Education/Experience/Skills

Bachelor’s degree in healthcare, life sciences or a related field. Targeting 10 years of progressively responsible experience in pharmacovigilance operations and or pharmacovigilance quality functions, with working knowledge of global pharmacovigilance requirements, preferably in a pharmaceutical or biotech environment.  An equivalent combination of relevant education and experience may be considered.

Key Skills:

• Strong knowledge of global pharmacovigilance regulations (e.g., FDA, EMA, MHRA, PMDA, Heath Canada) and industry best practices (ICH E2E, GVP modules), including safety monitoring and reporting in clinical trials, post-marketing surveillance, case processing, safety agreement requirements and reporting to Health Authorities worldwide.

• Experience representing PV in quality audits and inspections, including CAPA implementation.

• Proficiency in creating and maintaining quality systems, establishing and tracking performance metrics, compliance monitoring, developing and maintaining SOPs and training programs, and PV systems/databases.

• Ability to independently translate regulatory requirements into practical processes and drive cross-functional implementation.

• Demonstrated experience conducting regulatory gap assessments and developing or revising SOPs and work instructions.

• Effective written and verbal communication skills, including the ability to develop clear and concise documentation and training materials.

• Proficient in pharmacovigilance databases, quality systems, and training platforms.

• Demonstrated ability to drive operational excellence, inspection readiness, and process improvements.

• Ability to motivate and train others; drive standards and change across functional areas and sites.

• Strong attention to detail in establishing priorities, scheduling and meeting deadlines.

• Demonstrated strong analytical thinking, strategic writing, project management, and clear, effective communication across diverse stakeholders.

• Collaborate with internal teams, including Clinical Development, Medical Affairs, Regulatory Affairs, Quality Assurance, and Legal, to ensure alignment of PV quality strategies.

• Engage with external vendors and partners to ensure compliance with PV-related contractual agreements.

• Monitor and assess emerging regulations and industry trends to proactively enhance PV processes and ensure compliance.

• Foster continuous improvement by identifying process gaps related to PV and implementing best practices and ensuring scalable and efficient workflows.

• Contribute to the development of best practices, training materials, and procedural guidance.

• Promote a culture of accountability, compliance, and continuous improvement.

• Ability to manage multiple priorities and work cross-functionally in a fast-paced environment.
• Must be able and willing to travel on occasion.

Physical Requirements

This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds.  This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.

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