100% REMOTE - Pharmacovigilance Quality and Excellence

Location: Chicago, Illinois, United States
Salary: 401k, Medical, Dental, available to enroll
Job Type: Contract
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Quality in Pharmacovigilance Contractor


12 Month renewable contract

Support and drive discrete improvement projects relevant to the scope of the QPPV function.

  • To provide support for maintenance of Pharmacovigilance System Master File (PSMF), Summary of Pharmacovigilance System (SPS) and PRAC monitoring activities.
  • Provide project management support for dedicated project(s).

Typical Accountabilities

  • SupportanddrivePV Excellence byinputtingtoadhoc allocated tasks in relation to:
    • Developing and maintaining framework(s) for content quality measurement and oversight.
    • Assessing the effectiveness of initiatives with identification of subsequent further improvement actions as needed.
    • Developing standardised best practice templates, authoring instructions and guidance for production of Patient Safety outputs.
    • Promoting and ensuring Patient Safety outputs are produced in accordance with High Performance Authoring (HPA) principles.
    • Implementation of standards and skills with Patient Safety Therapeutic Area teams and individuals in close collaboration with Process Area Leads (PAL) and Process Owners (PO).
    • Ensuring the adoption of standards and skills by developing and providing process competence and capability build training to functional groups within Patient Safety.
    • Providing specialist knowledge and support to be recognized as experts and source of reference for safety teams and other stakeholders.
    • Contribution to the definition and assessment of measurable objectives and delivery targets.
  • Provide support for:
    • Maintenance of Pharmacovigilance System Master File (PSMF)
    • Summary of Pharmacovigilance System (SPS)
    • Monitor PRAC outputs per SOP
  • Provide project management support for dedicated projects

As needed:

  • Upon request participate and/or support activities for GVP audits/inspections

Education, Qualifications, Skills and Experience

  • Health professional degree (MD, PharmD, RPh, RN, or related degree) or master's degree in life sciences, or related field
  • Extensive experience in patient safety/pharmacovigilance including applicable industry experience and seen as a subject matter expert
  • Extensive operational experience in production of core safety outputs
  • Good knowledge and comprehension of relevant pharmacovigilance legislation
  • Excellent medical writing skills
  • Excellent communication skills
  • Experience and ability to develop and implement new standards and best practices
  • Strong project management skills
  • Proven ability to lead teams and collaborate in a continuous improvement
  • Regulatory strategy knowledge and experience
  • Clinical development knowledge and experience
  • Lean Sigma experience

Sthree US is acting as an Employment Business in relation to this vacancy.

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