Senior Manager, Global Risk Management

Senior Manager, Global Risk Management at Jazz Pharmaceuticals

Jazz Pharmaceuticals is a global biopharma company dedicated to innovating to transform the lives of patients and their families. They develop life-changing medicines for people with serious diseases, often with limited therapeutic options. With a diverse portfolio in sleep disorders, epilepsy, and a growing pipeline in oncology and neuroscience, Jazz is committed to a patient-focused and science-driven approach. Headquartered in Dublin, Ireland, the company has research and development laboratories, manufacturing facilities, and employees worldwide.

The Senior Manager, Global Risk Management plays a key operational support role within the GRADS Global Risk Management Team. This position is vital for supporting the development, implementation, execution, and monitoring of risk management activities, assessments, and documents for Jazz Pharmaceuticals products in Canada and globally. The role involves extensive cross-functional collaboration (e.g., with the Safety Management Team, QPPV, other functions, Canada affiliate, vendors) to ensure compliance with risk management processes and commitments, maintain inspection readiness, and support continuous improvement efforts through process development and training.

Essential Functions/Responsibilities

• Provide operational support to risk management activities for Jazz Pharmaceuticals products in Canada and globally.
• Track and monitor risk management plan submissions and activities.
• Collaborate with REMS Strategy & Operations and other business functions to ensure implementation and compliance with risk management plan requirements.
• Support the design and/or evaluations of additional pharmacovigilance activities and additional risk minimization measures, including effectiveness reports.
• Maintain awareness of updates to Health Canada regulations and industry guidance documents pertaining to pharmacovigilance risk management.
• Support Global Quality and GRADS Compliance in conducting/supporting audits and managing/facilitating inspections related to risk management activities.
• Provide pharmacovigilance risk management support for Canada regulatory submissions and queries.
• Help ensure appropriate Standard Operating Procedures for Canada risk management activities as required 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 provide review of risk management plans and other risk management documents (e.g., periodic safety reports, effectiveness reports) in collaboration with other business functions/affiliates.
• Provide input to and support compliance with contract requirements and related documents (e.g., master services agreements, safety data exchange agreements, business operations documents).
• Oversee vendor activities to ensure compliance with relevant documents and procedures.
• Support training, review, CAPAs, deviations, and change control management in collaboration with Quality, GRADS Compliance, and R&D Process Improvement and Training, for internal and external activities.
• Identify trends and areas for improvement in risk management practices.
• Contribute to developing/updating training and communication materials, including delivering training or roadshows on risk management processes to other business functions to foster awareness.
• Project manage risk management deliverables for Jazz products in Canada.
• Provide support to Global Risk Management operations globally.

Required Knowledge, Skills, And Abilities

• Knowledge of current and emerging regulatory requirements and expectations pertaining to risk management.
• Strong knowledge of global pharmacovigilance activities and processes including Health Canada, FDA, EMA, PMDA, MHRA.
• Strong understanding of PV Global Risk Management operations and compliance.
• Experience managing relationships with service providers and/or external business partners.
• Excellent teamwork and interpersonal skills with cross-functional team experience.
• Excellent oral and written communications skills.
• Skilled in conflict resolution/negotiation.
• Willingness to take on new challenges/opportunities (i.e., growth mindset).
• Ability to work cross culturally both in person and virtually.
• Proficiency with MS Office.
• Skill in inspiring and guiding others without formal authority.

Required/Preferred Education And Licenses

• BA/BS degree required. Health-related or biological science-related field, MA/MS, PharmD, RPh, or Nursing strongly preferred.
• Minimum of 6 years in pharmacovigilance required; risk management experience a plus.
• Excellent organizational skills with keen attentiveness to detail; project management experience 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, 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 and provides market competitive total compensation packages. For this role, the full and complete base pay range is $141,600.00 - $212,400.00. Individual compensation within this range depends on factors such as qualifications, skills, relevant experience, and job knowledge. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations also influence individual base pay decisions. This range is reviewed regularly.

At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan. Eligible candidates will also participate in various benefits offerings, including medical, dental, and vision insurance, 401k retirement savings plan, and flexible paid vacation.

Key skills/competency

• Risk Management
• Pharmacovigilance
• Regulatory Compliance
• Health Canada Regulations
• Cross-functional Collaboration
• Project Management
• Vendor Oversight
• SOP Development
• Audit & Inspection Support
• Process Improvement