Senior Manager Global Risk Management

Company Overview

Jazz Pharmaceuticals is a global biopharma company dedicated to innovating to transform the lives of patients and their families. We focus on developing life-changing medicines for serious diseases, often where therapeutic options are limited. Our diverse portfolio includes leading therapies for sleep disorders and epilepsy, alongside a growing pipeline of cancer treatments. Headquartered in Dublin, Ireland, Jazz Pharmaceuticals maintains research and development laboratories, manufacturing facilities, and employees across multiple countries, all committed to serving patients worldwide. For more information, please visit www.jazzpharmaceuticals.com.

Role Summary

The Senior Manager Global Risk Management plays a crucial operational support role within the GRADS Global Risk Management Team. This position is central to the development, implementation, execution, and monitoring of risk management activities, assessments, and documents for Jazz Pharmaceuticals products, specifically in Canada and globally. The role demands extensive cross-functional collaboration with teams such as Safety Management, QPPV, various internal functions, the Canada affiliate, and external vendors. Key responsibilities include ensuring compliance with risk management processes and commitments, maintaining inspection readiness, and actively supporting process development, training, and continuous improvement initiatives.

Essential Functions/Responsibilities

• Provide operational support for risk management activities concerning Jazz Pharmaceuticals products in Canada and globally.
• Track and monitor risk management plan submissions and associated activities.
• Collaborate with the REMS Strategy & Operations team and other business functions to ensure effective implementation and compliance with risk management plan requirements.
• Support the design and evaluation of additional pharmacovigilance activities and risk minimization measures, including effectiveness reports.
• Stay current with updates to Health Canada regulations and industry guidance pertinent to pharmacovigilance risk management.
• Assist Global Quality and GRADS Compliance in conducting/supporting audits and managing/facilitating inspections related to risk management activities.
• Offer pharmacovigilance risk management support for Canada regulatory submissions and queries.
• Help ensure appropriate Standard Operating Procedures (SOPs) for Canada risk management activities, as mandated by Health Canada, in collaboration with the Canadian team, GRADS Compliance, and R&D Process Improvement and Training (e.g., authoring and review of processes and associated documents).
• Represent Global Risk Management in cross-functional teams and forums.
• Develop and/or review risk management plans and other risk management documents (e.g., periodic safety reports, effectiveness reports) in partnership with other business functions/affiliates.
• Provide input into and support compliance with contract requirements and other related documents (e.g., master services agreements, safety data exchange agreements, business operations documents).
• Oversee vendor activities to ensure adherence to relevant documents and procedures.
• Support training, reviews, CAPAs, deviations, and change control management in collaboration with Quality, GRADS Compliance, and R&D Process Improvement and Training for both internal and external activities.
• Identify trends and opportunities for improvement in risk management practices.
• Contribute to the development and updating of training and communication materials, including delivering training or roadshows on risk management processes to other business functions to enhance awareness.
• Project manage risk management deliverables for Jazz products in Canada.
• Provide support to Global Risk Management operations globally.

Required Knowledge, Skills, And Abilities

• Strong knowledge of current and emerging regulatory requirements and expectations related to risk management.
• In-depth understanding of global pharmacovigilance activities and processes, including those governed by Health Canada, FDA, EMA, PMDA, and MHRA.
• Robust understanding of PV Global Risk Management operations and compliance.
• Proven experience managing relationships with service providers and/or external business partners.
• Excellent teamwork and interpersonal skills, with demonstrated cross-functional team experience.
• Exceptional oral and written communication abilities.
• Skilled in conflict resolution and negotiation.
• Possess a growth mindset and willingness to embrace new challenges and opportunities.
• Ability to work effectively cross-culturally, both in-person and virtually.
• Proficiency with MS Office applications.
• Adept at inspiring and guiding others without formal authority.

Required/Preferred Education And Licenses

• BA/BS degree required; a health-related or biological science-related field, MA/MS, PharmD, RPh, or Nursing strongly preferred.
• Minimum of 6 years in pharmacovigilance required, with risk management experience being a significant plus.
• Excellent organizational skills and keen attentiveness to detail; project management experience is desired.
• Experience in pharmaceutical quality and/or compliance is strongly preferred, ideally with audit/inspection experience.
• Familiarity with PV databases and regulatory information management systems (e.g., Veeva RIM); data management/analysis experience and/or computer system management experience are a plus.
• Experience with developing and/or managing process documents and/or change controls.
• Familiarity with Smartsheet and Miro.
• Fluency in French is a plus.

Compensation and Benefits (US based candidates only)

Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices. The full and complete base pay range for this role is $141,600.00 - $212,400.00. Individual compensation will vary based on qualifications, skills, experience, and other pertinent factors. The company aims to provide market-competitive total compensation packages, including discretionary annual cash bonuses or incentive compensation, and discretionary equity grants. Eligible candidates can also participate in comprehensive benefits offerings such as medical, dental, and vision insurance, a 401k retirement savings plan, and flexible paid vacation. More details on benefits can be found at: https://careers.jazzpharma.com/benefits.html.

Key skills/competency

• Global Risk Management
• Pharmacovigilance Regulations
• Regulatory Compliance
• Health Canada Regulations
• FDA, EMA, PMDA, MHRA
• SOP Development
• Project Management
• Cross-functional Leadership
• Vendor Oversight
• Risk Minimization Measures