N

Novartis

Global pharmaceutical company delivering science-based innovations

Medical Safety Lead - CRM

Biology & BiotechPosted on Nov 13
Full-time

About the Job

Requirements

  • A degree in Pharmacy, Nursing, Pharmacology, Life Sciences, or a medical degree is required; a medical degree is required for roles involving medical review of individual case safety reports.
  • Fluency in written and spoken English is required.
  • At least 3 years of experience in drug development within a pharmaceutical company is required.
  • Experience in clinical trial methodology, regulatory requirements, scientific methodology, and statistical principles, including authorship of scientific publications, is required.
  • Ability to analyse, interpret, and clearly communicate clinical safety data to diverse stakeholders is required.
  • Experience in safety and cross-functional issue management, such as regulatory inquiries, compliance issues, labelling updates, and risk escalations, is required.
  • Proven experience contributing to safety reports and regulatory documentation is required.

Responsibilities

  • Monitor clinical safety data, including literature, case reports, and signal detection activities.
  • Drive the application of AI-enabled solutions to simplify and enhance pharmacovigilance processes, leveraging knowledge of AI agents and their use in medical safety.
  • Conduct medical assessment of individual adverse event cases and ensure accurate evaluation.
  • Identify, evaluate, and monitor safety signals using single-case and aggregate data.
  • Contribute to responses for regulatory authorities and healthcare professional safety inquiries.
  • Support preparation of core safety documents, including clinical overviews and summary reports.
  • Provide medical input to aggregate safety reports and regulatory submissions.
  • Collaborate cross-functionally to integrate safety insights across global development teams.
  • Guide adverse event coding, causality assessment, and interpretation of clinical safety data.

Desired Qualifications

  • At least 2 years of experience in patient safety at an operational or medical position is preferred.
  • Experience using professional AI tools and agents for process improvement is strongly preferred.
  • Experience managing clinical safety issues is desirable.

About the Company

Novartis

Global pharmaceutical company delivering science-based innovations

Novartis is a global pharmaceutical company that uses science-based innovations to develop treatments and improve patient outcomes worldwide. Its products are medicines developed through research and development to address various diseases, aiming to reach nearly 1 billion people. The company differentiates itself by large-scale investment in R&D, a global presence with a diverse workforce, and a clear mission to Reimagine Medicine, focusing on meeting the changing needs of patients. Its goal is to improve quality of life and extend life expectancy by delivering meaningful therapies through its research and development efforts.

Company size
10,001+
Company stage
IPO
Headquarters
Basel, Switzerland
Founded
1970

Recently Posted Jobs

Explore more opportunities at Novartis

See more jobs