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Director, Global Pharmacovigilance Analytics & Safety Systems - United States  

Company managed [?] Still accepting applications

Posted on : 01 May 2017

Project Description

 

 

 

Position Summary

 

The Director, Global Head of GPV Systems is accountable for strategic decisions and oversight of all databases and applications that comprise the GPV system at Alexion including case intake, analysis, signal detection, ICSR reporting and aggregate reporting, to assure compliance with GVP, CFR and all applicable regulations and guidelines worldwide.  Oversight of technical vendors to maintain operation of PV Systems is a critical component of this position. The role is critical to GPV in supporting the safety surveillance of Alexion products globally and ensure compliance to global regulatory requirements, establish safety profiles of each Alexion product, and mitigate risk.

 

The Director, Global Head of GPV Systems is accountable for decisions relating to how the GPV system is designed, configured, implemented and maintained to meet changing needs of the Alexion business. The Director, Global Head of GPV Systems will manage others directly, indirectly, contractors and vendors and will be responsible for making decisions relating to that team and the applications deployed, and to the interfaces with other applications used within Alexion relevant to GPV and drug safety (eg Medidata Rave).  This position will therefore participate in regular strategic and tactical meetings with project teams conducting clinical studies and with programs managing potential sources of PV data including Patient Support Programs and Registries, and with the Business IT function at Alexion.

 

Principal Responsibilities

 

  • Business ownership of all applicable safety systems for GPV
  • Vendor oversight of those directly responsible for technical aspects of PV systems.
  • Responsible for risk-based decisions relating to the adoption and deployment of technical solutions relating to the acquisition, management, analysis and reporting of safety data for clinical programs and from post marketing sources globally
  • In partnership with functions across Alexion, develops and presents options for technological enhancements that deliver efficiency and effectiveness
  • Participate at industry-wide venues and continuously evaluate the market for emerging technologies that may improve departmental efficiency
  • Develops effective relationships with internal stakeholders and external vendors to ensure successful execution of business strategy for safety systems
  • Directs the medical coding and dictionary processes in accordance with applicable regulations and guidelines worldwide, incorporating regulatory changes
  • Provides governance of information management relating to safety data
  • Ensures training of technical and business users for data extraction/reporting functionalities and associated processes
  • Serves as primary interface for Business Support Administrators for ARGUS enterprise
  • Drives process and system-related change through established governance forums and partners to ensure appropriate training to users
  • Ensures all database locks are supported with high quality coded data without delays
  • Ensures all current medical terminology dictionaries are maintained and that clients are trained on use
    • Actively participates and represents the technical needs of GPV in cross-functional meetings (such as those with Informatics, Clinical, Regulatory, etc.) and in external technology driven meetings
    • Leads the design, implementation, and support of software applications and their upgrade/enhancement essential to GPV objectives
    • Oversees the safety database configuration
    • Roles, privileges, access
    • Library, parameter, code list maintenance
    • E2B implementation, maintenance, and error message monitoring
    • Ensures the activities for performance, of User Acceptance Testing (UAT) on GPV informatics initiatives, including regulatory submissions, corporate safety database, etc.
    • Supports regulatory inspections/audits; generation of requested listings for audits; produce validated output
    • Develops, implements and maintains database query and signal detection tools
    • Plans and oversees data migration activities when required
    • Produces customized metrics, outside of official metrics collected, needed by senior management

 

 

Qualifications

  • Excellent people and project leadership skills
  • Proven experience in technical vendor oversight
  • Excellent organizational and prioritization skills and strong analytical/problem solving skills
  • Excellent oral and written communication skills and commitment to mentoring /training PV team.
  • Experience in inspection preparation and demonstrated success in representing GPV in an inspection or audit
  • Demonstrated proficiency in global regulatory requirements, guidelines and industry best practices for pharmacovigilance
  • Proven skills to negotiate and operate in different cultural context
  • Analytic and strategic thinking in complex multi-cultural situations
  • Experience in working with vendors and business partners
  • Proficient in safety systems
  • Proven experience in group facilitation with the ability to drive teams to make decision and achieve deliverables within agreed parameters and timelines
  • Ability to interact effectively with staff of multiple disciplines both within and outside the company globally
  • Ability to lead in a high-pressure, fast paced and changing environment to ensure objectives are met in a timely manner and achieved within budget allocations
  • Subject matter expertise and technical excellence
  • Proven leadership skills related to execution of plans and process
  • Strong networking and influential skill to deal with potential conflict of stakeholder with the ability to bring a diverse group to a common decision
  • Experience interacting with regulators during inspections
  • Organizational expert within defined subject area
  • Mastery of medical coding terminology, conventions, systems, and practices
  • Create insightful and progressive functional strategy (multi-year)
  • Manage individual and group projects of moderate complexity
  • Vendor management experience

 

Education

  • Six (6) years of managerial experience directly managing people and/or leadership experience leading technical teams, vendors,  projects or programs

 

AND

  • Advanced degree preferred with minimum of 6 years of directly related experience (Management Information Systems, Computer Science, Informatics) with experience in  clinical or drug safety/ pharmacovigilance databases and systems

OR

  • Master's degree with minimum of 7 years of directly related experience (Management Information Systems, Computer Science, Informatics) with experience in  clinical or drug safety/ pharmacovigilance databases and systems

OR

  • Bachelor's degree and minimum of 9 years of directly related experience (Management Information Systems, Computer Science, Informatics) with experience in  clinical or drug safety/ pharmacovigilance databases and systems

 

 

Competencies

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As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Alexion, please visit www.alexionpharma.com or download our App for iPhones and Blackberries.

Alexion is an Equal Opportunity /Affirmative action employer   

 

New Haven, CT, United States
 

 

Alexion is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with devastating and rare disorders. Alexion developed and commercializes Soliris® (eculizumab), the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two life-threatening ultra-rare disorders. As the global leader in complement inhibition, Alexion is strengthening and broadening its portfolio of complement inhibitors, including evaluating potential indications for eculizumab in additional severe and ultra-rare disorders. Alexion’s metabolic franchise includes two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare disorders, Strensiq® (asfotase alfa) to treat patients with hypophosphatasia (HPP) and Kanuma™ (sebelipase alfa) to treat patients with lysosomal acid lipase deficiency (LAL-D). In addition, Alexion is advancing the most robust rare disease pipeline in the biotech industry, with highly innovative product candidates in multiple therapeutic areas.
As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Alexion, please visit www.alexionpharma.com or download our App for iPhones and Blackberries.

Alexion is an Equal Opportunity /Affirmative action employer