Medical Safety Lead - CRM

Healthcare Businesswomen’s Association; Barcelona; Presencial; EUR 70.000 - 90.000; Jornada completa

Descripción de la vacante

A leading healthcare organization is seeking a Medical Safety Lead in Barcelona to oversee safety evaluations and collaborate with global teams. Candidates should have a relevant postgraduate degree and a minimum of 4 years’ experience, including in patient safety. The role involves monitoring clinical safety data and contributing to regulatory documentation. Apply now to help reimagine medicine for millions of patients worldwide.

Formación

• Minimum 4 years of experience in drug development, including 2 years in patient safety.
• Proven ability to interpret and present safety data clearly and effectively.

Responsabilidades

• Monitor clinical safety data and literature to identify potential safety signals.
• Conduct medical assessments for individual cases and follow-ups.
• Collaborate with cross-functional teams on clinical safety deliverables.

Conocimientos

Clinical Trials

Pharmacovigilance

Regulatory Compliance

Medical Strategy

Safety Science

Educación

Master of Science / PharmD / PhD in a relevant field

Medical degree (MBBS or MD)

Descripción del empleo

Job Description 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!

Job Description

2 positions available within our Cardio Renal Metabolism Therapeutic Area

Location(s):

Barcelona, Spain or London, England

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

Role 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

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