Global Head of Clinical Safety

Galderma; Torrejón de Ardoz; Híbrido; EUR 100.000 - 150.000; Jornada completa

Descripción de la vacante

A leading dermatology company is seeking a Global Head of Clinical Safety to oversee medical safety for products in clinical development. This hybrid role involves managing a team and ensuring compliance with pharmacovigilance standards while positively impacting patients with dermatological conditions.

Servicios

Inclusive work environment

Competitive compensation and benefits

Hybrid work culture

Personalized career development

Formación

• At least 12 years in global clinical safety/pharmacovigilance.
• 3-5 years in team management.

Responsabilidades

• Develop and update Risk Management Plans (RMPs).
• Manage aggregate safety reports (DSUR, PSUR, PBRER).
• Lead safety data reviews during clinical trials.

Conocimientos

Team Management

Risk Management

Signal Detection

Safety Data Review

Educación

Medical degree (M.D.)

Additional degrees in pharmacology

Descripción del empleo

Galderma is a leading dermatology company present in approximately 90 countries, offering innovative, science-based skincare and therapeutic products. Since 1981, our focus has been on meeting individual needs with superior outcomes, emphasizing diversity, teamwork, and personal growth.

We are establishing a new Global Capability Center in Barcelona, located in the Eixample District, which offers opportunities for professional development and global exposure.

Job Title

Global Head of Clinical Safety

Location

Barcelona, Spain (hybrid)

Job Description

The Global Head of Clinical Safety will oversee medical safety for products in clinical development, focusing on biologics like Nemolizumab. Responsibilities include signal detection, risk management, safety analyses, and managing pharmacovigilance relationships. The role involves medical review of safety data, team management across locations, and significant interaction with senior management, aiming to positively impact patients with dermatological conditions.

Key Responsibilities

• Develop and update Risk Management Plans (RMPs)
• Monitor safety profiles, validate signals, and propose risk mitigation measures
• Manage aggregate safety reports (DSUR, PSUR, PBRER)
• Contribute to safety modules for regulatory submissions and respond to safety inquiries
• Lead safety data reviews during clinical trials
• Escalate safety issues to governance bodies
• Ensure compliance with PV audits and inspections
• Collaborate with internal stakeholders
• Manage a team of up to 5 direct reports

Skills & Qualifications

• Medical degree (M.D.) required
• At least 12 years in global clinical safety/pharmacovigilance, with 3-5 years in team management
• Experience with international clinical development and post-marketing regulations, especially biologics
• Experience with safety data from US, EU, and other regions
• Knowledge of global pharmacovigilance requirements
• Additional degrees in pharmacology, pharmacovigilance, or epidemiology preferred

What we offer

• Inclusive work environment reflecting diverse perspectives
• Competitive compensation and benefits
• Hybrid work culture
• Personalized career development
• Ownership and accountability in a growing company

Next Steps

• Initial virtual interview with recruiter
• Interview with hiring manager
• Panel interview with the team

At Galderma, our people make a difference. Join us to work with diverse, talented colleagues in a supportive environment.