Advanced Recruiting Partners · 5 days ago
Vice President, Patient Safety and Pharmacovigilance
United States
Full-time
Remote
Director/Executive
15+ years expAdvanced Recruiting Partners is seeking a Vice President for Patient Safety & Pharmacovigilance, who will lead the development and maintenance of a global pharmacovigilance system. This role involves ensuring compliance with safety regulations and collaborating with various departments to uphold safety governance and operational excellence.
Human ResourcesRecruitingStaffing Agency
Responsibilities
Establish and oversee a best-in-class global pharmacovigilance system, including the development of standard operating procedures (SOPs), compliant workflows, and cross-functional safety governance frameworks
Lead the design, implementation, and continuous improvement of product safety and risk management plans across all development and post-marketing programs
Direct signal detection and evaluation activities, including review of individual case safety reports (ICSRs), aggregate trend analyses, and literature surveillance
Identify, assess, and manage potential safety signals using data-driven mitigation strategies
Partner with internal teams and external collaborators to support safety analyses, risk assessments, and benefit-risk evaluations throughout product development and commercialization
Select, manage, and oversee external pharmacovigilance vendors and service providers, ensuring accountability for deliverables, regulatory compliance, quality, and budget performance
Lead preparation of safety-related components of regulatory submissions, including clinical protocols, Investigator’s Brochures, Safety Review Committee charters, and related documentation
Serve as primary author and reviewer of responses to safety-related regulatory inquiries
Oversee the development and timely submission of aggregate safety reports (e.g., DSURs, PSURs, PADERs) and expedited safety reports in compliance with global regulatory requirements
Chair internal safety review committees and provide medical and safety input into clinical development programs
Maintain inspection and audit readiness and support regulatory inspections as required
Qualification
Required
Bachelor's or Master's degree in a scientific, biological, life sciences, or related discipline
Minimum of 15 years of clinical trial or drug development experience, with at least 5 years in a senior leadership role demonstrating success in people and project management
Proven experience at the Vice President or Senior Director level leading complex Phase III programs in a fast-paced biotechnology or pharmaceutical environment
Demonstrated success implementing innovative, technology-enabled approaches to support clinical development timelines
Proficiency with clinical trial systems and platforms (e.g., CTMS, eTMF, EDC, IRT) and tools supporting trial execution and inspection readiness
In-depth knowledge of clinical operations and the pharmaceutical drug development process, including experience within neuroscience or related therapeutic areas
Strong understanding of cross-functional clinical trial processes from study start-up through close-out, including data management, safety, biostatistics, and medical writing
Experience managing global studies and geographically dispersed teams
Working knowledge of industry standards and regulations, including ICH guidelines, GCP, CFR, and familiarity with FDA, EMA, and other international regulatory requirements
Experience contributing to or supporting NDA or other regulatory submissions
Demonstrated ability to manage multiple programs, priorities, budgets, and timelines across early- to late-stage development
Strong project management skills with the ability to work independently, lead initiatives, and drive high-quality outcomes
Ability to assess complex issues and develop creative, practical solutions
Proven capability to build and maintain effective relationships with vendors, investigators, consultants, and internal stakeholders
Excellent written, verbal, and presentation communication skills
Proficiency in Microsoft Project and/or other project management tools, as well as Microsoft Office applications (Excel, Word, Outlook, PowerPoint)
Company
Advanced Recruiting Partners
Advanced Recruiting Partners is a staffing agency that offers recruiting services for biopharmaceutical and life science industries.
2-10 employees
Funding
Current Stage
Early StageLeadership Team
Christopher Young
COO
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