Global Program Safety Lead

hace 4 semanas


Madrid, Madrid, España Novartis A tiempo completo

Job Description:

As a Global Program Safety Lead at Novartis, you will be responsible for designing and developing safety surveillance strategies for products and approvals. This includes overseeing the company's drug surveillance program, including follow-up, risk assessment, and relatedness to product adverse reaction reports. You will also be responsible for safety in clinical trials and post-marketing programs, as well as 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 and actively participate in the Global Program Team (GPT), Global Clinical Team (GCT), and Clinical Trial Team (CTT).
  • Manage safety issues from the formation of the GPT through Life Cycle Management.
  • Oversee overall signal detection, monitoring, evaluation, interpretation, and appropriate management of safety information, based on data from all relevant line functions, post-marketing data, and other sources.
  • 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.
  • Lead the preparation of the safety strategy for health authority responses and collaborate with other project team members.
  • Contribute to and often lead the development of departmental and functional/business unit goals and objectives.
  • Manage the distribution of marketing samples, where applicable.

Requirements:

  • Medical Degree required
  • 8+ years of experience in Big Pharma
  • Skills: Clinical Research, Clinical Trials, Functional Teams, Leadership, Medical Strategy, Process Safety Management, Regulatory Compliance, Risk Management, Safety Science
  • Fluent English (both spoken and written) is mandatory. Additional languages are an advantage


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