The Senior Director, Global Pharmacovigilance Operations & Systems provides strategic and operational leadership for global pharmacovigilance operations. The role is accountable for case processing, safety systems, aggregate reporting operational support, vendor governance, inspection readiness, operational excellence, compliance, and organizational scalability.

This leader serves as a critical member of the Pharmacovigilance team and partners closely with Clinical Development, Regulatory Affairs, Quality, Medical Affairs, Biostatistics, Data Management, and external partners to ensure the timely, compliant, and efficient execution of all pharmacovigilance activities supporting both development and commercial products.

Key Responsibilities

Strategic Leadership

• Develop and execute the global PV Operations strategy aligned with organizational goals and regulatory requirements.
• Build a fit for purpose, scalable operating model to support portfolio growth, geographic expansion, and commercialization.
• Contribute to departmental strategy, long-range planning, organizational design, resourcing, and workforce planning. Anticipate future needs and build scalable capabilities.
• Lead transformation initiatives focused on automation, digitalization, and process optimization.

Global Pharmacovigilance Operations

• Oversee end-to-end ICSR intake, processing, coding, quality review, and regulatory submission.
• Ensure compliance with global PV regulations and reporting requirements.
• Oversee operational support for DSURs, PBRERs/PSURs, PADERs, and other safety deliverables.
• Maintain strong quality, compliance, and regulatory reporting performance.
• Coach and mentor functional leaders as needed.

Vendor Governance and Outsourcing

• Oversee PV vendors and outsourced service providers.
• Define governance, service levels, quality metrics, and performance management processes.
• Conduct business reviews and drive continuous improvement across vendor partnerships.
• Ensure accountability and inspection readiness across outsourced activities.

Safety Systems and Technology

• Lead PV technologies and safety systems.
• Partner with IT and Digital teams to optimize performance, compliance, and data governance.
• Champion automation, advanced analytics, and AI solutions where appropriate.
• Maintain validated, compliant system environments.

Quality Oversight and Inspection Readiness

• Drive continuous quality improvement and inspection readiness.
• Support regulatory inspections and internal and partner audits.
• Ensure timely, effective CAPA execution.
• Monitor quality indicators and risks; implement mitigation plans as needed.

Operational Excellence

• Establish and monitor performance metrics, dashboards, and KPIs.
• Lead process harmonization and standardization.
• Improve efficiency, quality, scalability, and cost-effectiveness.
• Maintain business continuity and risk management plans.
• Anticipate future needs and build scalable capabilities.

Qualifications & Experience

• Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Public Health, or related field required.
• Advanced degree preferred, such as MS, PharmD, PhD, MD, MPH, or MBA.
• 15+ years of progressive PV experience in pharmaceutical, biotechnology, or CRO settings.
• 8+ years leading global PV Operations in a biotech or pharmaceutical setting.
• Significant experience with outsourced operating models and vendor governance.
• Extensive experience with safety databases, case processing, and regulatory reporting.
• Proven success supporting regulatory inspections and remediation.
• Experience implementing safety technologies and leading operational transformation.
• Deep knowledge of global PV regulations, GVP, FDA regulations, and ICH guidelines.
• Sustained compliance and inspection readiness, as well as timely, high-quality regulatory reporting.
• Proven track record of delivering on strategic operational initiatives, as well as meeting operational and quality metrics.
• Extensive experience in vendor oversight and governance, ensuring expected outcomes are delivered.
• Deep understanding of the drug development lifecycle from IND through commercialization.
• Proven ability to lead cross-functional, global teams.
• Ability to operate as an enterprise leader with strategic and operational impact, build effective relationships and enhance engagement.
• Experience influencing at senior leadership levels, aligning teams around shared objectives.
• Strong risk management, problem-solving, and decision-making skills in complex environments.
• Excellent organizational, communication, and interpersonal skills.
• Ability to thrive in a fast-paced environment with ambiguity and competing priorities.
• Authorization to work in the United States.
• Ability to travel up to approximately 15%.

Pay Range and Benefits:

Base Salary Range: $280,000 - $311,081 USD

Individual compensation will be determined based on factors such as work location, skills, education, training, and experience.

What we offer US-based Employees:

• Competitive base, bonus, new hire and ongoing equity packages
• The starting compensation range(s) for this role is for a full-time employee (FTE) basis
• Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment
• Employer-paid Medical, dental, and vision insurance
• Employer-paid life insurance, AD&D, short-term disability, long-term disability, and EAP coverage
• 401(k) Plan with a fully vested company match 1:1 up to 4% of contributions
• Employee Stock Purchase Plan
• 14 -18 paid holidays, including office closure between December 25th and January 1st
• Flexible vacation
• Sick time
• Fitness Program
• Get Outdoors Program
• Paid parental leave benefit
• Tuition assistance

Job Type: Full-Time

Work authorization: United States (Required)

Work Location: Remote flexibility with periodic in-person collaboration

Equal Opportunity Employer: Tyra Biosciences, Inc. is an equal opportunity employer that is committed to providing a work environment free of harassment and discrimination based upon a protected category, as well as an environment free from retaliation for protected activity.

Notice to Recruiters and Third-Party Agencies: The Talent Acquisition team manages the recruitment and employment process for Tyra. To protect the interests of all parties involved, Tyra will only accept resumes from a recruiter once a fully executed search agreement is in place. Agencies are hereby specifically directed not to contact Tyra employees directly in an attempt to present candidates. Tyra will consider any candidate for whom an Agency and/or Recruiter has submitted an unsolicited resume to have been referred, free of any charges or fees.