Case Management Specialist

Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in neuroscience and oncology. We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. For more information, please visit www.jazzpharmaceuticals.com and follow @JazzPharma on Twitter.

Overview

Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in neuroscience and oncology. We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. For more information, please visit www.jazzpharmaceuticals.com and follow @JazzPharma on Twitter.

Position Profile

The Case Management Specialist is responsible for participating in and enabling the timely and accurate collection, safety review, processing and reporting of adverse event data in compliance with applicable global regulations and Jazz Pharmaceuticals standard operating procedures and guidelines.   They may perform, or enable Jazz PV Service Provider to perform, accurate computer data entry of identified adverse event information and ensure the uniform and timely processing and reporting of adverse events to regulatory authorities. The Specialist will participate in the set-up and maintenance of adverse event workflow and be accountable for the development of department policies and standard operating procedures. The Case management Specialist may assist in special projects as assigned by the Pharmacovigilance (PV) department management.

The Case Management Specialist may be assigned to Intake & Submissions or Global Case Processing.

 Key Intake & Submissions Team activities may include, but are not limited to: Timely intake, reconciliation and submission of Individual Case Safety Reports (ICSRs) to and from destinations including but not limited to global regulatory authorities, business partners, investigators, and ethics committees in compliance with applicable global regulations/reporting requirements and Jazz Pharmaceuticals standard operating procedures and guidelines. In addition, may contribute to the department relationship with internal and external business partners to meet global regulatory reporting requirements and support other Jazz Pharmaceutical business area needs related to AE Intake or reporting.

• Regulatory Intelligence Review for ICSR Intake & Submission Requirements, and reference tracking tool maintenance
• Authoring and maintaining AE Intake and ICSR Submissions processes and standards, including AE follow-up
• Act as an expert resource for AE Intake and ICSR Reporting Requirements and system configuration requests associated with, but not limited to, :
• Med Affairs/Commercial programs, Product Launches, RWE & Mkt Research programs, Product Withdrawal or license transfer, social media, Business Partner case exchange etc.
• Perform or oversee Serious ICSR Finalizations & Submissions –
• Input to ICSR exchange timelines in Business Partner SDEAs, maintain reference tracking tool, and initiate requests to SSM for configuration/update of associated system rules for Business Partner SDEAs
• ICSR Reconciliations from all sources other than Clinical
• Ensure proactive quality of delivery by PV Service providers and internal Jazz staff for AE Intake & Submission activities
• Operational vendor oversight – AE intake vendor (s)

Key Global Case Processing Activities may include but are not limited to:  High quality and timely assessment, coding, data entry, and quality review of ICSRs in the Global Safety Database according to Jazz standards and conventions for corresponding case types.  In addition, may contribute to the department relationship with cross functional internal stakeholders to ensure case processing conventions meet global regulatory requirements as well as the needs of other Jazz Pharmaceutical business areas for signal detection, aggregate data analysis, risk management activities, periodic safety reports, responding to regulatory queries, and other pharmacovigilance activities.  

• Authoring and Maintaining standards & requirements for ICSR processing in the Global Safety Database, including queries, requests for follow up and case corrections.
• Act as an expert resource for ICSR processing in the Global Safety database, and system configuration requests associated with, but not limited to:
• Expectedness tables finalized by Medical Safety, Surveillance requirements, targeted safety questionnaires, REMS/RMP, PADER/PBRER/PSUR/DSUR, Product Safety Guides, protocols/study specific guides, safety management plans, Global standards and definitions,
• Establishes or performs proactive quality control measures to ensure complete and accurate case information has been entered into the drug safety database
• Perform or oversee case processing transition to vendors, including training
• Perform case processing for Clinical Study ICSRs including reconciliation
• Perform case processing for post-marketed products as needed
• Operational vendor oversight
• Proactively ensure uniform, high quality, and timely processing of ICSRs in the Global Safety Database by Global PV Service provider and internal Jazz staff for Global Case processing activities

Case Management Specialist Essential Functions

• Adheres to company templates and GxP guidelines for documentation and communications
• Ensures compliance with corporate and departmental policies, standard operating procedures, and timely completion of all assigned training
• Other duties as required to support case management operations and teams
• Participate in the development and maintenance of adverse event case management workflow processes, department policies, work instructions, standard operating procedures and training material when new and/or updated processes are introduced
• May assist in coordinating the department’s workflow and assist with special projects under the direction of the CM department management.
• May serve as an individual contributor or a project manager for functional projects or workflows.
• May mentor other CM team members, including service providers
• Participation in Inspections and Audits as identified, as well as active role in maintaining a business-as-usual inspection ready state of operating
• Takes responsibility for personal development and continuous improvement including keeping up to date with pharmacovigilance practices, legislation and guidelines.
• Work collaboratively with the PVAM, R&D Quality, PV Quality & PV Compliance teams to evaluate the performance, identify bottlenecks, minimize regulatory risks and recognize patterns of inefficiencies in current operational processes

Minimum Requirements

• BS/BA degree in health related or biological science related field
• 3 plus years of pharmaceutical drug safety/pharmacovigilance operations experience.
• Experience of case entry
• Knowledge of FDA and international regulations pertaining to Adverse Event and ICSR requirements, as well as ICH guidelines, including the ability to interpret and apply applicable regulations to inform decisions and resolve issues
• Experience in obtaining, analyzing, disseminating, and reporting safety information in compliance with global regulations
• Proficiency in standard desktop software programs (Word, Excel, Outlook)
• Experience using or familiarity with safety database applications
• Experience using MedDRA and MedDRA coding

• Understanding of medical terminology and ability to summarize medical information
• Excellent oral and written communication skills
• Highly organized and demonstrates consistent attention to detail
• Must demonstrate accountability for delivery of results and have good problem-solving and decision-making skills
• Must be able to manage their own work, with ability to prioritize, plan and organize work assignments while working under strict timelines
• Must be quality oriented and demonstrate consistent attention to detail
• Must have the ability to follow established processes and the flexibility to adopt new practices and priorities as required, with a continuous improvement mindset
• Must have the ability to work collaboratively as part of a team in a fast-paced dynamic environment
• Flexibility to work outside of normal working hours or on-call arrangements

Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.

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