Medical Safety Lead

hace 5 horas

Barcelona, España Novartis A tiempo completo

**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**:
**#**LI-Hybrid**

**Primary Location**: Barcelona, Spain

**Secondary Location**: Madrid, Spain

**Work Model**: Hybrid

**About the role**:
**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

Division

Development

Business Unit

Universal Hierarchy Node

Location

Spain

Site

Barcelona Gran Vía

Company / Legal Entity

ES06 (FCRS = ES006) Novartis Farmacéutica, S.A.

Alternative Location 1

Madrid Delegación, Spain

Functional Area

Research & Development

Job Type

Full time

Employment Type

Regular

Shift Work

No

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

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