NOVARTIS Hiring Safety Labelling Manager Health-Care Professional – Physician or Pharmacist Apply Now
Your responsibilities include, but are not limited to:
Performs tasks assigned as per applicable procedures (e.g., GOPs,
SOPs, WIs), including tasks assigned in harmonized GOPs/SOPs/WIs as per the
role mapping in the applicable role matrix.
Provides timely and adequate updates of the core safety information,
supported by expert statements and commented track change versions of the CDS.
Prepares data packages required by 3rd party providers. Reviews and
qualifies CDSs deliveries from providers; creates new CDS as needed.
Ensures patient safety through timely and adequate updates of the
core safety information of marketed products.
Tracks signals in the signal management tracking system, and
evaluates line listings and safety information in scientific literature,
including reference product information and regulatory authority communication.
Manages 3rd party providers for the production of CDS and related
documents. Plans and initiates CDS updates/periodic reviews with service
provider.
Presents safety issues to the Safety Management Board / other
internal boards as needed. Trains and develops / coaches new colleagues
(internal and/or external) supporting the CDS team.
Is responsible for department output regarding timeliness, volume
and high quality of CDSs. Keeps WIs / SOPs / GOPs for the area of
responsibility up to date with internal (e.g., QMs) and external (e.g., GVP
modules) requirements, provides input to such procedural documents of other
functions, and ensures implementation of such procedural documents in the area
of responsibility.
Minimum requirements
Health-Care Professional – Physician or Pharmacist; Desirable:
Health-Care Professional with MD, PhD
Skills/Behaviors; at least 4 years PV or label experience and
regulatory
Considers HA + internal stakeholder input appropriately; simplifies
+ standardizes routine activities to the extent possible, while not
compromising on scientific product knowledge + evaluations;
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