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Associate Director, Global Case Management – Global Pharmacovigilance

Company: Jazz Pharmaceuticals
Location: Palo Alto
Posted on: October 10, 2021

Job Description:

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.

The Associate Director Global Case Management, Global Pharmacovigilance, directs and supervises the operational and management activities of multiple Managers and their teams.  Reporting into, and under the direction of, the Sr. Director Global Case Management, PV Alliance Management & SDEAs, Global Pharmacovigilance, this highly experienced Pharmacovigilance leader will be responsible for setting the standards for Individual Case Safety Report (ICSR) management worldwide.  This leader will serve as an influential change agent when changes are implemented in GCM and will ensure the highest standards of ICSR quality and compliance for all Jazz products throughout the life cycle.  By establishing and maintaining robust standards for ICSR management, this leader will ensure the availability of high-quality data for signal management and analysis, as well as timely reporting to key stakeholders including Health Authorities and Jazz Business Partners. 

The Associate Director will liaise with cross functional customers and stakeholders within Jazz to proactively ensure nuance stakeholder requirements are met, and key safety data are available in a standardized and easily retrievable way, as well as to clarify case management procedures & requirements.   The leader will work closely with the Case Management team, R&D IT, Safety Systems Management, and others across Pharmacovigilance to drive the implementation of validated, automated solutions. 

This role can be remote

Essential Functions

  • Manages direct reports in the Global Case Processing and Intake and Submissions sections of the Global Case Management team as required including performance management, staff development plans, effective coverage, and succession planning.

  • Provides expertise, leadership, and direction to the Global Case Management team, and participates as a member of GCM, PVAM & SDEA LT to inform strategic decision-making pertaining to GCM and the department

  • Partners with the Sr. Director to establish the strategy for the Global Case Management team that is aligned with the GCM, PVAM & SDEA department and Global Pharmacovigilance organization strategies

  • Implements the strategy for GCM section

  • Maintains a global perspective of the business need for accurate, high-quality safety data management and reporting in a cost-effective manner, while maintaining regulatory and internal procedural compliance

  • Delivers high-quality and timely inputs in support of GCM, PVAM & SDEA department business plans and priorities

  • Continuously assesses and maintains in-depth knowledge of Health Authorities in major markets, including regulations, expectations, contacts, and ensures that upcoming changes in legislation pertaining to ICSR management are effectively implemented

  • Ensures compliance with worldwide regulatory requirements for patient safety, and ensures corrective and preventive actions are taken in the event of non-compliance

  • Ensures that after-hours and business continuity processes for AE reporting are in place, and tested annually to allow for responding to regulatory authority inquiries or inspection

  • Ensures that filing, archiving and data handling practices in GCM follow the relevant Jazz policy for document retention, privacy compliance, security, and search and retrieval.

  • Ensures that processes and systems are in place for accurate and compliant recording, processing, translation, and reporting of AEs/AE reports from all clinical and post-marketed sources

  • Ensures that regulatory requirements for ICSR reporting are defined, with respect to local Health Authorities worldwide and ethics committees and investigators, and ensures these reports are tracked with applicable audit trails

  • Ensures processes and tools support timely reconciliation with business partners, countries, and internal teams to effectively validate the receipt and reporting of AEs on Jazz products

  • Ensures the legal team are informed of threatened, possible or actual legal action

  • Ensure inspection readiness across the GCM team

  • Ensure effective training plans and competency assessments for all aspects of ICSR management, as well as timely delivery internally and externally

  • Works closely with Manufacturing Quality to ensure the needed compliance with connecting and reporting between product quality complaints and adverse events

  • Works closely with Medical Information to ensure the needed compliance with connecting and reporting between medical information inquiries and adverse events

  • Ensures adequate resource planning and management for GCM to ensure effective function of the team.

  • Provides Operational and Strategic oversight of the PV Service Providers for AE intake as well as Global Case Processing to ensure Service Provider delivers to quality, compliance, and performance KPI/SLAs

  • Identifies opportunities for/instigates/leads change in the case handling process – seeking continuous improvement based on good awareness of competitive practice

  • Provides regular updates to Sr. Director GCM, PVAM & SDEAs

  • Coaches and mentors staff to deliver high quality output, including providing and facilitating regular feedback to individuals and within team.

  • Participation in Inspections and Audits

  • Develops and fosters a culture of quality, compliance, diversity, inclusion, and learning within the team and department.

  • Supports a performance driven culture with visible performance metrics, personal development of staff, and visible recognition and rewards

  • Performs other activities as directed by department management.

Required Knowledge, Skills, and Abilities

  • Comprehensive working knowledge of FDA, EMA, MHRA, PMDA, Health Canada and ICH regulations relevant to pharmacovigilance and AE reporting

  • Extensive prior experience in ICSR case processing, PV quality management systems, and PV compliance including major PV inspections

  • Commitment to and experience in evaluating and implementing digital solutions in PV operations including automation and machine learning

  • Experience working with CROs and vendors for ICSR services

  • Business acumen

  • Able to work with a high degree of autonomy in a fast-paced environment

  • Experience working with Global teams and cultures

  • Demonstrated leadership and professional skills, ability to resolve conflict

  • Demonstrated record of professional excellence – background of high professional achievement and motivating others in this

  • Ability to influence while maintaining independent and objective views

  • High ethical standards and commitment to Jazz values & behaviors

  • Project management experience preferred

  • Knowledge of the end-to-end drug development and commercialization process preferred

  • Experience working with Oracle (Relsys) Argus a plus.

  • Must be self-motivated, detail-oriented and ability to multi-task.

  • Must possess excellent communication (oral and written) and complex problem-solving skills.

  • Must have strong leadership, interpersonal/organizational skills.

  • Flexibility to work outside of normal working hours or on-call arrangements.

Required/Preferred Education and Licenses

  • Bachelor’s Degree in biosciences or healthcare related field

  • At least 6 years Patient Safety Operations experience

  • Minimum 2+ years people management (direct reports) or 4+ years of leading project teams (no formal direct reports but responsible for leading teams with project deliverables).

  • MBA a plus

  • Lean Sigma a plus

  • Project Management a plus

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.

Keywords: Jazz Pharmaceuticals, Palo Alto , Associate Director, Global Case Management – Global Pharmacovigilance, Other , Palo Alto, California

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