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Job Overview
Employment Type
Full-time
Compensation
Salary
Range $99,500.00 - $170,700.00
Benefits
Medical insurance
Dental Insurance
Vision Insurance
401k retirement savings plan
Flexible paid vacation
Discretionary annual cash bonus
equity grants
Job Description
Jazz Pharmaceuticals is a global biopharmaceutical company committed to innovating and transforming the lives of patients and their families through the development of life-changing medicines. Focused primarily on serious diseases with limited or no therapeutic options, Jazz has a diversified portfolio that includes leading therapies in the areas of sleep disorders and epilepsy, complemented by a growing array of cancer treatments. This company adopts a patient-focused and science-driven approach that powers pioneering research and development efforts. Their robust pipeline centers on innovative therapeutics in oncology and neuroscience. Headquartered in Dublin, Ireland, Jazz operates research and development laboratories and manufacturing facilities... Show More
Job Requirements
- BA/BS degree in a health-related or biological science-related field
- Minimum of 6 years of pharmacovigilance experience
- Strong knowledge of global pharmacovigilance activities and processes including Health Canada, FDA, EMA, PMDA, MHRA
- Strong understanding of pharmacovigilance global risk management operations and compliance
- Experience managing relationships with service providers and/or external business partners
- Excellent teamwork and interpersonal skills
- Excellent oral and written communication skills
- Skilled in conflict resolution and negotiation
- Willingness to take on new challenges and opportunities
- Ability to work cross-culturally both in person and virtually
- Proficiency with MS Office
Job Qualifications
- BA/BS degree in a health-related or biological science-related field
- MA/MS, PharmD, RPh, or Nursing degree preferred
- Minimum of 6 years of pharmacovigilance experience
- Risk management experience is a plus
- Excellent organizational skills with keen attentiveness to detail
- Project management experience desired
- Experience in pharmaceutical quality and/or compliance preferred
- Audit/inspection experience desirable
- Familiarity with PV databases and regulatory information management systems such as Veeva RIM preferred
- Data management, analysis, or computer system management experience is a plus
- Experience developing and/or managing process documents and change controls
- Familiarity with Smartsheet and Miro
- Fluency in French is a plus
- Excellent teamwork and interpersonal skills
- Excellent oral and written communication skills
- Skilled in conflict resolution and negotiation
- Ability to work cross-culturally both in person and virtually
- Proficiency with MS Office
- Skill in inspiring and guiding others without formal authority
- Willingness to take on new challenges and opportunities
Job Duties
- Provide operational support to risk management activities for Jazz Pharmaceuticals products in Canada and globally
- Track and monitor risk management plan submissions and risk management activities
- Collaborate with REMS Strategy and 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 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
- Represent Global Risk Management in cross-functional teams/forums
- Develop and/or provide review of risk management plans and other risk management documents in collaboration with other business functions/affiliates
- Provide input to and support compliance with contract requirements and other related 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
- 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
- Project manage risk management deliverables for Jazz products in Canada
- Provide support to Global Risk Management operations globally
Job Qualifications
Experience
Expert Level (7+ years)
Job Location
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