Job Title: Director, PV Operational Excellence

Work Location: Remote-EST/CST

Summary:

The Director, PV Operational Excellence is responsible for ensuring quality oversight and compliance of Pharmacovigilance (PV) activities throughout the product lifecycle. This role will collaborate with leadership and cross-functional teams to maintain regulatory compliance, oversee vendor management, and drive continuous improvement in PV quality systems.

Responsibilities:

• Develop and implement global quality and compliance programs to ensure regulatory adherence across the pharmacovigilance system.
• Lead the creation and management of processes for handling PV quality issues, CAPAs, and late case investigations.
• Oversee the establishment, review, and communication of key quality and compliance indicators within the PV system.
• Collaborate with cross-functional leadership to ensure all PV activities meet regulatory and internal standards.
• Drive inspection readiness initiatives and lead function-level activities to maintain ongoing preparedness.
• Partner with Quality Assurance on regulatory intelligence and departmental training, including setting and monitoring training requirements.
• Provide strategic direction and global oversight for PV quality initiatives, fostering a culture of quality and compliance.
• Work with IT and QA teams to oversee outsourced safety databases and ensure robust PV system infrastructure.

Qualifications:

• 12+ years of experience in pharmacovigilance.
• Advanced degree in a scientific discipline (PharmD, MD, PhD) preferred.
• Extensive knowledge of FDA, EMA, ICH guidelines, and regulations for safety reporting and clinical trial environments.
• Experience with MedDRA, WHO Drug Dictionary, and safety database systems (e.g., Argus, ArisG, Veeva Safety).
• Proven experience in developing and reviewing SOPs and Work Instructions.
• Demonstrated vendor management oversight, including post-marketing PV vendor and global safety database setup.
• Strong organizational, analytical, and problem-solving skills; ability to adapt in a fast-paced environment.
• Excellent verbal and written communication skills, with the ability to present to internal and external stakeholders.
• High integrity, commitment to patient safety, and strong ethical standards.
• Proficiency with Microsoft Office suite (Word, PowerPoint, Excel, Outlook, SharePoint, etc.).
• Ability to travel up to 10-15% as required.

Published Category: Pharmacovigilance