Pharmacovigilance Quality & Excellence at Real Staffing in Chicago, Illinois

Real Staffing

Chicago, Illinois
October 20, 2020
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100% REMOTE - Pharmacovigilance Quality and Excellence

Quality in Pharmacovigilance Contractor100% REMOTE12 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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Job Expires: November 19, 2020

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