Medical Safety Lead

Summary

Join Novartis and make a profound impact on patient safety! As a Medical Safety Lead, 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!

About the Role

Note: We are currently recruiting for various Therapeutic Areas, and your application will be considered for all relevant positions.

Key Responsibilities

• 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

Essential 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

• Medical degree (MBBS or MD) with specialization preferred
• Experience managing clinical safety issues

Languages

• Fluent English (both spoken and written) is mandatory.
• Additional languages are an advantage.

Accessibility and accommodation

Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to receive more detailed information about the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.