Global Program Safety Lead

Vor 6 Tagen


Basel, Basel-Stadt, Schweiz Novartis Vollzeit
Job Description

As a Global Program Safety Lead - Immunology, you will be responsible for designing and developing safety surveillance strategies for products and approvals. You will oversee the company's drug surveillance program, including follow-up, risk assessment, and relatedness to product adverse reaction reports. Additionally, you will be responsible for safety in clinical trials and post-marketing programs, participating in the resolution of legal liability and complying with governmental regulations.

Key Responsibilities:
  • Provide expert safety input to the clinical development program for assigned projects/products.
  • Manage safety issues from the formation of the Global Program Team (GPT) through Life Cycle Management.
  • Oversee overall signal detection, monitoring, evaluation, interpretation, and appropriate management of safety information.
  • Ensure proper documentation, tracking, and record-keeping of medical safety activities for assigned compounds.
  • Respond to inquiries from regulatory authorities or healthcare professionals regarding safety issues.
Requirements:
  • Medical Degree required.
  • 8+ years of experience in Big Pharma.
  • Fluent English (both spoken and written) is mandatory. Additional languages are an advantage.
About Novartis:

Our purpose is to reimagine medicine to improve and extend people's lives. We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.



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