Director, Pharmacovigilance Operations
Position Overview
The Director, Pharmacovigilance (PV) Operations is responsible for the strategic leadership, oversight, and execution of global pharmacovigilance operational activities supporting clinical development and future commercial products.
Requirements
Develop and execute the pharmacovigilance operational strategy to support ongoing clinical development programs and future commercial products
Establish scalable processes, governance structures, and operating models that support organizational growth
Maintain a state of continuous inspection readiness across all pharmacovigilance activities
Support vendor selection, qualification, contracting, and implementation activities
Provide operational oversight for the preparation and submission of aggregate safety reports and for safety updates supporting regulatory submissions and health authority interactions
Participate in safety governance meetings
Support regulatory submissions, product launches, business development activities, and partnership due diligence efforts
Drive operational excellence through process standardization, automation, and continuous improvement initiatives
Minimum Requirements
Education: Bachelor's degree in nursing, pharmacy, or related life sciences discipline; advanced degree preferred
Experience: 10+ years of pharmacovigilance experience within biotechnology, pharmaceutical, or CRO environments; 5+ years of leadership experience in pharmacovigilance operations, vendor management, or safety systems
Licenses or Certifications: US Licensure preferred
Knowledge, Skills And Attributes
Strong working knowledge of global pharmacovigilance regulations, including FDA, EMA, ICH, and GVP requirements
Experience overseeing outsourced pharmacovigilance models and vendor governance
Experience supporting regulatory inspections, audits, and quality management activities
Experience implementing or managing Argus, ARISg, Veeva Safety, or comparable safety systems
Experience supporting commercial launch readiness activities
Excellent oral and written communication skills
Outstanding interpersonal skills and ability to develop a rapport with cross-functional partners that enable highly effective collaboration
Flexibility in a changing environment (e.g., balancing individual priorities vs evolving organizational needs)
Ability to act expeditiously with deliberateness and intention
Continuous strong focus on meeting or exceeding expectations in executing deliverables, performance, and results
Self-starter with high degree of energy, independence, initiative, and self-motivation, as illustrated by the ability to instill a sense of pace and urgency into the team
Passionate, collaborative, creative, willing to take prudent risks, and motivated by the creation of a company focused on transformative treatments for patients and their families