Novartis Safety Labelling Manager Vacancy – Pharma Job
Novartis Safety Labelling Manager – Pharma Jobs. Applications are invited for the post of Safety Labelling Manager @ Novartis.Career @ Novartis. Pharma job opportunity at Novartis.vacancy at Novartis. Check out all the details on the same below:
Job Title: Safety Labelling Manager
Job Id: 301321BR
• 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;
• Collaborates with all partner functions effectively; strong ownership + compliance/quality mindset.
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.
• 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 the 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 the 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.
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