job description.

Are you experienced in Pharmacovigilance or Drug safety? We are now looking for a Pharmacovigilance expert / Drug Safety expert for an exciting consultant assignment at AstraZeneca with start in September.

Short role description
  • 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).


responsibilities.

Support and drive PV Excellence by inputting to ad hoc 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

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


qualifications.

Essential
  • 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
  • Good strategic thinking capability

Desirable
  • Regulatory strategy knowledge and experience
  • Clinical development knowledge and experience
  • Lean Sigma experience
For us, it is important that all competence and skills in the labor market are utilized. We welcome all applicants and strive for diversity.


application.

2020-08-26, selection and interviews will be ongoing. The position may be filled before the last day of application, therefore, apply as soon as possible.

For more information: Birgitta Nyström birgitta.nystrom@randstad.se or Eleonor Ehrman +46733434109. 



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Drug Safety expert AstraZeneca Gothenburg

Randstad AB

Kategori: Övrigt
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Nyckelord

Audits, Communication skills, LEAN, Management, Monitor, Project management, Sigma