Head of US PS PV Case Management

Head Of Us Ps Pv Case Management

Ready to lead at the forefront of patient safety and pharmacovigilance? As Head of US PS PV Case Management, you will shape how critical safety information is captured, processed, and delivered ensuring patients remain at the center of everything we do. This is a high-impact leadership role where you will drive end-to-end case management excellence, champion digital and artificial intelligence-enabled transformation, and build high-performing teams that deliver quality, compliance, and innovation at scale. You'll play a pivotal role in safeguarding patients while transforming the future of pharmacovigilance operations in a dynamic, globally connected environment.

Key Responsibilities:

• Lead end-to-end case management operations, including case intake, triage, processing, follow-up, quality control, case corrections and submission ensuring timely, accurate, and compliant safety reporting.
• Serve as the primary operational escalation point for complex, sensitive, or high-risk case processing issues and case-related risks and operational challenges.
• Ensure compliance with FDA regulations, ICH standards, and internal requirements.

• Oversee vendor performance, governance, and capacity models to optimize delivery and resource mix.
• Maintain robust workload forecasting and capacity models; optimize in-house vs. vendor mix, responsible for resourcing.
• Drive quality, compliance, and performance through key performance indicators, audits, and inspection readiness initiatives.

• Champion digital, automation, and artificial intelligence solutions to enhance efficiency and data quality
• Identify and drive continuous process improvement initiatives, applying Lean and data-driven methodologies to simplify, standardize, and harmonize case handling processes.

• Build, coach, and develop high-performing teams, fostering a culture of continuous improvement and accountability.
• Foster a culture of quality, compliance, accountability, continuous improvement, inspection readiness and learning.

• Serve as a key partner across internal and external stakeholders on adverse event reporting and case management, proactively identifying and mitigating issues to ensure aligned, effective, and compliant processes.
• Coordinate with Global Countries and Regions for simplified/harmonized practices and case exchange and collaborate with Regulatory Affairs, Quality, Legal/Data Privacy, Risk Management, and Medical Safety to support submissions, inspections, signal detection, RMPs, REMS, labeling updates, and periodic reports.

Essential Requirements:

• Bachelor's degree in a relevant life sciences or healthcare-related field. An advanced degree is preferred (Pharm. D., M.D., Ph.D.).
• 10+ years pharmacovigilance experience with 7+ years leading case management teams and vendors in medium-to-large pharma/biotech, including regulatory submissions.
• Strong knowledge of FDA PV regulations and ICH E2A/E2D/E2B(R3); deep understanding of MedDRA coding and case medical evaluation.
• Hands-on strong expertise with safety databases (Argus, Veeva Vault Safety, or similar), E2B(R3) case exchange, Electronic Data Capture (EDC) systems, call center telephony systems, and quality systems.
• Experience with drug, biologics, medical devices and combination products.
• Experience with project management and process excellence methodologies (e.g., Lean, Six Sigma).
• Strong leadership capability, with a track record of developing high-performing teams and driving operational excellence.
• Demonstrated capability to influence, provide strategic direction, negotiate, and resolve complex regulatory and operational challenges.
• Demonstrated experience leading inspections, audits, and ensuring inspection readiness.
• Proven people leadership experience, including coaching and developing managers and teams.
• Excellent planning, communication, interpersonal, and organizational skills, with a demonstrated ability to think innovatively and strategically at an enterprise level.
• Ability to lead cross-functional teams and deliver complex transformation initiatives, including digital automation and artificial intelligence solutions.
• Experience with patient support program data flows and third-party oversight.
• Expertise in workflow design, resourcing, budgeting, and performance monitoring.

The salary for this position is expected to range between $204,000 and $379,000 per year.

Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.

US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.