Key responsibilities
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Maintains oversight of the management of safety
information, safety risk management and all other
pharmacovigilance (PV) activities in NNSH GSP for both Drug
and Device.
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Ensure PV medical compliance (NN policies and standards,
global and local regulation requirement) and inspection readiness.
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Design and execution of safety strategy and ensure high
quality deliveries.
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Develop and implement safety related quality system.
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Independently perform proactive safety surveillance and
risk management to effect product safety signal detection
and evaluation, risk assessment and safety risk mitigating.
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Timely collecting and reporting AE from costumer to
local HA AE system related NNSH.
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Analysis and evaluate AE trends, develop risk reduce plan.
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Monthly PV metrics/report calculation and preparation.
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Deviation identification and reporting to Head of GSP QA.
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Support data collection and preparation for MAH.
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Cooperate group level PV team to make sure NN internal
compliance.
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Engagement in audit and inspection readiness and support
as PV SME.
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Safety/PV related training material development and
execute in NNSH GSP level.
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Drug &MD PV related regulation collection in China
and Shanghai level.
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Regulation collection and analysis.
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Quality related document management support.
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Quality Audit support for NNSH GSP.
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Vendor, supplier, distributor quality management support.
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RDC quality oversight.
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AE related record management.
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Other duties as assigned by line manager.
Qualification
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Bachelor degree or above in pharmacy, biology, chemistry,
medicine or other related area
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Above 5 years product safety and PV experience.
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Good English skill at reading, writing, listening and speaking.
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Good communication skills of both scientific and
non-scientific information.
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Professional knowledge in local regulations.
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Problem solving ability and skills.
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Ability to face challenge and self-learning.
We commit to an inclusive recruitment process and equality
of opportunity for all our job applicants.
At Novo Nordisk we recognize that it is no longer good
enough to aspire to be the best company in the world. We need to
aspire to be the best company for the world and we know that
this is only possible with talented employees with diverse
perspectives, backgrounds and cultures. We are therefore
committed to creating an inclusive culture that celebrates the
diversity of our employees, the patients we serve and
communities we operate in. Together, we’re life changing.