Senior Executive Director

Galderma; Barcelona; Híbrido; EUR 120.000 - 180.000; Jornada completa

Descripción de la vacante

A leading company in dermatology, Galderma, is seeking a Global Head of Clinical Safety to oversee medical safety assessments and lead a global pharmacovigilance team. This hybrid role involves significant responsibilities in clinical safety management, requiring extensive experience and a robust knowledge base in drug development and safety requirements.

Formación

• 12 years' experience in global clinical safety or pharmacovigilance role.
• 3 to 5 years of line management experience required.
• Sound knowledge of pharmacovigilance and safety regulations.

Responsabilidades

• Provide medical safety expertise for benefit/risk assessment of products.
• Line manage a team of pharmacovigilance staff globally.
• Lead safety data review during clinical trials.

Conocimientos

Team Management

Pharmacovigilance

Risk Management

Signal Detection

Clinical Safety

Educación

Additional degree in clinical pharmacology and/or pharmacovigilance/drug safety and/or epidemiology

Descripción del empleo

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Join to apply for the Global Head of Clinical Safety role at Galderma

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. At Galderma, we actively give our teams reasons to believe in our bold ambition to become the leading dermatology company in the world. Further supporting our growth and innovation momentum, we are establishing a new Global Capability Center in Barcelona to deploy new capabilities to effectively support its global commercial and functional teams. Located in the upscale Eixample District in the heart of Barcelona, Galderma’s Global Capability Center offers numerous possibilities for professional development such as exposure to global and cross-functional projects and access to global career opportunities.

Job Title : Global Head of Clinical Safety

Barcelona, Spain (hybrid)

As the Global Head of Clinical Safety, you will be responsible for providing medical safety expertise for the benefit / risk assessment of products in clinical development, with a specific focus on our key biologic (Nemolizumab). This involves signal detection, risk management, risk mitigation / management plans, safety analyses in aggregate reports, providing input into publications and data dissemination activities and managing the PV relationship with a key business partner.

This position is also responsible for the medical review of safety-related information in study protocols, study reports, investigator brochures, product labelling (including CCDS), periodic / aggregate reports, risk management plans and responses to specific questions from health authorities.

The Global Head of Clinical Safety will line manage a team of pharmacovigilance (PV) staff in different locations around the world who are focused primarily on clinical development PV activities across the development portfolio but which will increasingly involve some post-marketing surveillance and lifecycle management activities as well.

This role will have a significant degree of autonomy and will be highly visible within the organization with broad exposure to senior management. The role reports to the Global Head of Pharmacovigilance Risk Management

release and update the Development Risk Management Plans (DRMPs)

Partner with internal and external stakeholders to ensure monitoring of safety profile for assigned compounds, signal validation and signal evaluation, and propose appropriate risk management and risk minimization measures

Take ownership of aggregate safety reports (e.g. Take ownership of (development) Risk Management Plans (RMP)

Provide input into safety modules for dossier submission and contribute to answers to safety-related questions from regulatory agencies and internal / external stakeholders

Contribute to investigator / KOL meetings for safety-related aspects / questions

Contribute to IDMC (Independent Data Monitoring Committee) meetings, and support due diligence activities, as needed

Lead ongoing safety data review during clinical trials through Safety Plans and safety review meetings

Escalate and present safety issues at company governance bodies

Ensure effective collaboration with Global Regulatory Affairs, Global Medical Affairs, the Clinical Development group, Commercial and other internal stakeholders

12 years' experience in a global clinical safety / pharmacovigilance role (with an emphasis on drug development) in an ethical pharmaceutical company

Minimum 3 to 5 years of line management experience of a team of Safety Physicians and / or Scientists is required

Interactions to address safety medical questions related to clinical studies (e.g. Summary of Clinical Safety, Clinical Overview, RMP) with health authorities in the US, EU and other geographies required

Sound knowledge of the global pharmacovigilance and safety requirements for non-clinical and clinical development, registration process and post-marketing, required

Additional degree in clinical pharmacology and / or pharmacovigilance / drug safety and / or epidemiology, preferred

You will be able to work in a hybrid work culture.

If your profile is a match, we will invite you for a first virtual conversation with the recruiter.

The next step is a virtual conversation with the hiring manager.

Professionalism, collaboration, and a friendly, supportive ethos is the perfect environment for people to thrive and excel in what they do.

Employment type Full-time

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