Posted to MedZilla on 11/14/2019


Takeda Pharmaceuticals

US-MA, Associate Director PV Processes R0013333-MZ


 
 

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Job Description

Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as an Associate Director PV Processes in our Cambridge office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As an Associate Director PV Processes working on the PV Services team, you will be empowered to Create and Strategize. A typical day will include:

OBJECTIVE: .

  • Serve as a primary liaison and point of contact for vendor operations and vendor oversight, including vendors performing case management, case intake (i.e., Call Centers), scientific literature review, etc.
  • Provide Subject Matter expertise (SME) during audits and inspections in the areas of case processing/case management activities, literature monitoring, legal case processing, vendor oversight, etc.
  • Lead initiatives to identify and implement improvements to quality, compliance, productivity, innovation and efficiency of case processing and related activities.
  • 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 of GPSE Operations and vendor activities to ensure adverse event information is processed according to defined timelines and quality standards
  • Manage activities including PVA contract compliance, partner reconciliation
  • Line management of GPSE team members, as required, including mentoring, development, training and performance appraisal
  • 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 development and implementation of appropriate SOPs, processes, case handling conventions, metrics, and monitoring of performance and compliance
  • Oversee and direct reconciliation activities for case exchange with partners in accordance with PVAs
  • Oversee and direct reconciliation processes for case exchange with LOCs and alliance partners
  • Interface with commercial quality for product complaints; assist in obtaining follow-up when necessary for adverse events, product quality complaints or other safely information
  • Lead PV relationship with PV BPO vendor and/or vendors performing case management to ensure compliance with SLAs
  • Direct relationship with and output of BPO partner(s) or vendors performing case management or expedited reporting and submissions in accordance with SLA
    • Liaises with financial / project management for budget planning
    • Approve actual invoices and confirm accuracy of spend and bills
    • Coordinate clinical and project management case processing teams to assess / predict case volumes to ensure staffing planning at vendor
    • Lead planning for ad-hoc case processing related projects e.g. Legal cases or AE/SAEs generated through marketing surveys
    • 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
    • Manage / review delivery against MSA terms
    • Monitor global KPIs and SLAs
    • Ensure quality of deliverables across teams
    • Represent voice of vendor to PV function
    • Provide guidance to delivery teams
    • Maintain operating manual (describing operating rules with vendor)
    • 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 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 Senior PV managementInterface with commercial quality for product complaints; assist in obtaining follow-up when necessary for adverse events, product quality complaints or other safely information
  • Direct relationship with and output of BPO partner(s) in accordance with SLA
    • Liaises with financial / project management for budget planning
    • Approve actual invoices and confirm accuracy of spend and bills
    • Coordinate clinical and project management case processing teams to assess / predict case volumes to ensure staffing planning at vendor
    • Lead planning for ad-hoc case processing related projects e.g. Legal cases or AE/SAEs generated through marketing surveys
    • 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
    • Manage / review delivery against MSA terms
    • Monitor global KPIs and SLAs
    • Ensure quality of deliverables across teams
    • Represent voice of vendor to PV function
    • Provide guidance to delivery teams
    • Maintain operating manual (describing operating rules with vendor)
    • Lead change management and ongoing training
  • Establish and manage vendor oversight procedures
  • Partner with QA to establish and manage BPO vendor quality agreement procedures 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 Senior PV management

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:

  • 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
  • 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 Takeda business needs and global strategy
  • Demonstrated effectiveness in external partner relationship management
  • Understanding of medical/scientific terminology
  • Excellent understanding of safety databases, including search and code dictionaries
  • Excellent written/oral communication skills able to present at internal and cross-functional meetings
  • Accuracy and attention to detail, flexible mindset, team worker with collaborative approach
  • Develop, review, write documents including SOPs, Job Aids, and others, as required
  • 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; Excellent understanding of safety databases, including data entry, navigation, and use of code dictionaries such as MedDRA and WHO Drug
  • Advanced knowledge of Global PV regulations (pre and post market), i.e., FDA, EMA, ICH GVP

TRAVEL REQUIREMENTS:

Some travel to global Takeda sites may be required.

WHAT TAKEDA CAN OFFER YOU:

  • 401(k) with company match and Annual Retirement Contribution Plan
  • Tuition reimbursement
  • Company match of charitable contributions
  • Health & Wellness programs including onsite flu shots and health screenings
  • Generous time off for vacation and the option to purchase additional vacation days
  • Community Outreach Programs

Empowering Our People to Shine

Learn more at takedajobs.com.

No Phone Calls or Recruiters Please.

#LI-KL1

Locations

Cambridge, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time


Please visit our website at takedajobs.com

 
 


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