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An exciting consultant opportunity, starting 15-09-2020, has arisen for a highly motivated Pharmacovigilance Expert/Drug Safety Expert at AstraZeneca Gothenburg. We are looking for a person with knowledge and experience in regulatory strategy, clinical development and Lean Sigma.

For further details around this position you are welcome to contact Jenny Lundkvist at [email protected]. Welcome with your application no later than 26th of August.

Om tjänsten
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).

Dina arbetsuppgifter i huvudsak
Typical Accountabilities:
• Support and drive PV Excellence by inputting to ad hoc allocated tasks in relation to:
o Developing and maintaining framework(s) for content quality measurement and oversight.
o Assessing the effectiveness of initiatives with identification of subsequent further improvement actions as needed.
o Developing standardised best practice templates, authoring instructions and guidance for production of Patient Safety outputs.
o Promoting and ensuring Patient Safety outputs are produced in accordance with High Performance Authoring (HPA) principles.
o 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).
o Ensuring the adoption of standards and skills by developing and providing process competence and capability build training to functional groups within Patient Safety.
o Providing specialist knowledge and support to be recognized as experts and source of reference for safety teams and other stakeholders.
o Contribution to the definition and assessment of measurable objectives and delivery targets.

• Provide support for:
o Maintenance of Pharmacovigilance System Master File (PSMF)
o Summary of Pharmacovigilance System (SPS)
o 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

Vem är du?
• 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

• Regulatory strategy knowledge and experience
• Clinical development knowledge and experience
• Lean Sigma experience

Om verksamheten
At AstraZeneca, we turn ideas into life changing medicines. We win through science, it’s at the heart of our every success. That science is only possible when we all work together – we’ll always make sure you’re clear about how your role is connected to our wider mission to really show what science can do.

Are you ready to make a difference?
Send in your application, and we’ll make it happen together.

Detta är en jobbannons med titeln "Pharmacovigilance Expert / Drug Safety Expert" hos företaget Poolia Sverige AB och publicerades på workey.se den 14 augusti 2020 klockan 16:13.

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