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Global Head of Clinical Safety

Galderma

Santander

Híbrido

EUR 100.000 - 150.000

Jornada completa

Hace 11 días

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Descripción de la vacante

A leading company in dermatology is seeking a Global Head of Clinical Safety to provide medical safety expertise for clinical development. This role involves managing safety assessments, leading a team, and ensuring compliance with regulations, all within a hybrid work environment in Barcelona.

Servicios

Diversity and inclusion focus
Competitive compensation and benefits
Hybrid work environment
Personalized career development
Empowering growth environment

Formación

  • 12+ years in global clinical safety/pharmacovigilance with management experience.
  • Knowledge of international drug development and biologics regulations.
  • Experience with safety questions from health authorities.

Responsabilidades

  • Propose measures to minimize risks during clinical development.
  • Manage aggregate safety reports and lead safety data reviews.
  • Collaborate with various internal teams and manage a team of up to 5 direct reports.

Conocimientos

Medical Safety Expertise
Risk Management
Team Leadership
Pharmacovigilance
Signal Detection

Educación

MD Degree
Additional degrees in pharmacology or epidemiology

Descripción del empleo

Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin shapes our lives, we are advancing dermatology for every skin story.

We look for people who focus on results, embrace learning, and bring positive energy. They must combine initiative with teamwork and collaboration. Above all, they must be passionate about making a meaningful difference for consumers, patients, and healthcare professionals. We aim to empower employees and promote personal growth while meeting business needs. We embrace diversity and respect everyone's dignity, privacy, and rights.

At Galderma, we aim to become the leading dermatology company globally. Joining us offers opportunities to gain new experiences and create a significant impact.

We are establishing a new Global Capability Center in Barcelona to support our global teams. Located in the Eixample District, it offers opportunities for professional development through exposure to international projects and global career paths.

Job Title

Global Head of Clinical Safety

Location

Barcelona, Spain (hybrid)

Job Description

Responsible for providing medical safety expertise for product benefit/risk assessments during clinical development, focusing on biologic Nemolizumab. Tasks include signal detection, risk management, safety analyses, and managing PV relationships. The role involves medical review of safety information, managing a team of PV staff worldwide, and collaborating with senior management to impact patient lives positively.

Key Responsibilities
  1. Propose measures to minimize risks during clinical development and update Risk Management Plans.
  2. Partner with stakeholders to monitor safety profiles, validate signals, and propose risk measures.
  3. Manage aggregate safety reports (DSUR, PSUR, PBRER).
  4. Lead safety data reviews and escalate safety issues to governance bodies.
  5. Ensure compliance with PV audits and inspections.
  6. Collaborate with various internal teams.
  7. Manage a team of up to 5 direct reports.
Skills & Qualifications
  • MD degree required.
  • 12+ years in global clinical safety/pharmacovigilance, with management experience.
  • Knowledge of international drug development and biologics regulations.
  • Experience with safety questions from health authorities.
  • Additional degrees in pharmacology or epidemiology preferred.
What we offer in return
  • Diversity and inclusion focus.
  • Competitive compensation and benefits.
  • Hybrid work environment.
  • Personalized career development.
  • Empowering growth environment.
Next Steps
  • Initial virtual interview with recruiter.
  • Interview with the hiring manager.
  • Panel interview with the team.
Our people make a difference

We value diversity and professionalism, fostering a supportive environment for all team members.

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