Senior Manager, Global Risk Management

The Sr. Manager - Global Risk Management plays a key operational support role in the GRADS Global Risk Management Team, supporting the development, implementation, execution, and monitoring of risk management activities, assessments, and documents for Jazz Pharmaceuticals products in Canada and globally. This role will collaborate cross-functionally (e.g., with the Safety Management Team, QPPV, other functions, Canada affiliate, vendors) and will be responsible for ensuring compliance with risk management processes and commitments and inspection readiness, and supporting process development, training, and continuous improvement efforts.

Essential Functions/Responsibilities

• Provide operational support to risk management activities for Jazz Pharmaceuticals products in Canada and globally.
• Track / monitor risk management plan submissions and risk management activities.
• Collaborate with REMS Strategy & Operations team 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, e.g., in 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 to conduct/support audits and manage/facilitate inspections pertaining to risk management activities.
• Provide pharmacovigilance risk management support for Canada regulatory submissions/queries.
• Help ensure appropriate Standard Operating Procedures for Canada risk management activities as required by Health Canada in collaboration with 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/forums.
• Develop and/or provide review or 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/other 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 of risk management practices.
• 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 but not limited to 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.

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