PRAHS

  • Associate Director of Pharmacovigilance Processes

    Job Locations - | US-IL-Chicago
    Posted Date 5 days ago(5 days ago)
    ID
    2018-48000
  • Overview

    Do you want to watch clinical development change, or do you want to be the one to shape it?

     

    Because we’re hoping you’re here for the latter.

     

    Who are we?

    We Are PRA.

     

    We are 16,000+ employees strong, operating in more than 85 countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We are getting live saving drugs into the hands those who need them most.

     

    Who are you?

    You are a forward thinker. You are an innovator that refuses to settle. You want to push the boundaries and change not just what it means to be a PV Reports Analyst; You want to change the future.  You want to learn from the best, grow your knowledge and your skill set, and you want to build your career here. You want to use the latest technology and tools in the industry to push the momentum of an already growing company forward. You want to find a balance that still lets you be, well, you. Most of all, you want to do it in a place where you’re more than an employee number. A place you love working.

     

    Still here? Good. Because if this is you, we’d really like to meet you.

     

     

    Responsibilities

    • Oversight of case processing vendors ensuring adherence to SLA’s (Service level agreements)
    • Identify, lead and oversee the transition of new projects and operations performed by the PV BPO vendor or vendors performing case management or literature review
    • Serve as the Lead for Case Management executing operational strategies to ensure contract compliance, quality and timeliness of deliverables and continuous improvement efforts in collaboration with GPSE colleagues(Global Patient Safety Evaluation) and Case Management vendors
    • Serve as the primary liaison and point of contact for vendor operations including the PV BPO vendor and/or vendors performing case management, case intake, literature review or expedited reporting and distribution
    • Ensure continuous collaboration with Global Pharmacovigilance and the wider organization to maintain harmonised operations and integrated functioning in support of compliance to regulations

    Accountabilities:

     

    • Provide leadership and oversight on case management for the Global PV Operations Team to ensure adverse event information is processed according to company timelines and quality standards
    • Line management of internal Pharmacovigilance team including mentoring, development, training and appraisal
    • Oversight of regulatory submissions activities for ICSRs from the Global Safety database, on-time delivery of adverse event reports to global Health Authorities, alliance partners, local operating companies (LOCs) including SUSAR and SAE communication to ECs and investigators as applicable
    • In partnership with the Global Standards and Compliance team, direct and manage communication with alliance partners, LOCs and CROs regarding the evaluation and processing of ICSRs
    • In partnership with the Global Standards and Compliance team, lead and direct the review and approval of alliance partner safety data exchange agreements for the inclusion of appropriate safety reporting requirements
    • Ensure overall performance of the department and compliance with global regulatory requirements by implementation of appropriate SOPs, processes, metrics, and monitoring of performance and compliance, and training at a global level
      • Oversee and direct reconciliation processes for case exchange with LOCs and alliance partners
      • Lead PV relationship with PV BPO vendor and/or vendors performing case management to ensure compliance with SLAs
      • Support LOCs in PV tasks responding to queries and requests regarding case handling
      • Direct relationship with BPO partner(s) in accordance with SLA
      o Coordinate clinical and project management case processing teams to assess / predict case volumes to ensure staffing planning at vendor
      o Lead planning for ad-hoc case processing related projects e.g. Legal cases or AE/SAEs generated through marketing surveys
      o Lead and facilitate regular joint operating committee meetings to review / address issues if needed for:
       Adherence to KPIs and SLAs
       Forecast demand
       Issue escalations
       Continuous improvement initiatives
       Change management
      o Manage / review delivery against MSA terms
      o Monitor global KPIs and SLAs
      o Ensure quality of deliverables across teams
      o Represent voice of vendor to PV function
      o Provide guidance to delivery teams
      o Maintain operating manual (describing operating rules with vendor)
      o Lead change management and ongoing training
      • Establish and manage vendor oversight procedures
      • Support audit and inspection activities as appropriate, including preparation and corrective and preventative action planning
      • Partner with QA to establish and manage BPO vendor quality agreement procedures to include vendors performing case management/intake activities or literature review and surveillance
      • Develops, manages and implements projects and process improvement activities as required
      • Any other activities as delegated by GPSE management

    **  This role is located in our Deerfield, IL office and not a remote role. **

    Qualifications

    • Bachelor’s required. Advanced degree in scientific/medical field preferred
    • Good cross-cultural understanding and experience
    • Significant pharmaceutical or health care related industry experience required.
    • Global experience with CROs, vendors and relationship management preferred
    • Experience in people management and well-developed skills in teambuilding, motivating and developing people
    • Demonstrated skills in negotiation and consensus decision making
    • Critical thinking and analytical skills and ability to make key decisions in cross-functional and global environments.
    • Understanding of and contribution to client business needs and global strategy
    • Demonstrated effectiveness in external partner relationship management
    • Understanding of medical/scientific terminology
    • Expert knowledge of Global Pharmacovigilance regulations for Clinical and and post marketing
    • Excellent understanding of safety databases, including search and code dictionaries
    • Excellent written/oral communication skills
    • Accuracy and attention to detail
    • Flexible mindset
    • Team worker with collaborative approach
    • Able to interact with personnel from all functional areas at all levels including externally to represent the department and company in a highly professional manner
    • Ability to prioritize under pressure with the ability to successfully manage multiple critical issues simultaneously
    • Well-developed organizational skills and able to prioritize individual and departmental workloads
    • Good level of computer literacy with Microsoft applications

     

    • Minimum 8 years pharmaceutical or health care related industry experience required.
    • Minimum 6 years PV experience with 4 years experience working with CROs, vendors, and relationship management required

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