Senior Manager, Global Risk Management

Description

• 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.

Qualifications

• 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.