Medical Safety Lead

hace 15 horas

London, Greater London, España Novartis A tiempo completo

Band

Level 5

Job Description Summary

Join Novartis and make a profound impact on patient safety

As our Medical Safety Lead in our Cardio Renal Metabolic team, you'll spearhead safety evaluations, collaborate with dynamic global teams, and craft safety strategies that not only protect patients but also drive groundbreaking medical innovation.

Be a part of something extraordinary

Job Description

Primary Location: Barcelona (Grand Via), Spain

Working Model: #LI-Hybrid Hybrid (12 days per month on-site)

Alternate Location: London (The Westworks), United Kingdom

Working Model(s) #LI-Hybrid Hybrid (12 days per month on-site if living within 50 miles of our London office)

#LI-Remote Remote (if living beyond 50 miles of our London office)

About the role:

Major accountabilities:

  • Monitor clinical safety data, literature, and case reports to identify potential safety signals
  • Conduct medical assessments for individual cases, including follow-ups and quality defect evaluations
  • Perform signal detection and evaluation using aggregate and single-case data
  • Contribute to regulatory responses and prepare safety data for health authority reviews
  • Support safety input for core data sheets and related regulatory documentation
  • Provide medical input for aggregate safety reports and risk management plans
  • Collaborate with cross-functional teams on clinical safety deliverables and study documentation
  • Offer expert evaluation on adverse event reports and guide pharmacovigilance operations

Minimum Requirements:

  • Master of Science / PharmD / PhD in a relevant field
  • Fluent in spoken and written English; additional language skills are a plus
  • Minimum 4 years of experience in drug development, including 2 years in patient safety
  • Strong knowledge of clinical trial methodology, regulatory requirements, and scientific analysis
  • Proven ability to interpret and present safety data clearly and effectively
  • Experience contributing to clinical safety assessments and regulatory safety reports

​Desirable Skills:

  • Medical degree (MBBS or MD) with specialization preferred
  • Experience managing clinical safety issues
  • Experience in Cardio/Renal/Metabolic therapy area

Ready to make a difference? Apply now and help us reimagine medicine for millions of patients worldwide.

Skills Desired

Clinical Trials, Functional Teams, Literature Review, Management Skills, Medical Information, Medical Records, Medical Strategy, Pharmacovigilance, Regulatory Compliance, Risk Management, Safety Science

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