Descripción de la oferta
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, we are in shapes our lives, we are advancing dermatology for every skin story.
We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients, and the healthcare professionals we serve every day. We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy, and personal rights of every employee.
At Galderma, we actively give our teams reasons to believe in our bold ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact.
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.
Global Pharmacovigilance Risk Minimization Physician - Therapeutic DermatologyLocation: Barcelona, Spain
At Galderma, we're unique and we embrace difference.
Whether it's the unique breadth of our integrated offering that covers Aesthetics, Consumer, and Prescription products, or our commitment to recognising and rewarding people for the contribution they make - working here isn't like anywhere else.
At Galderma, we actively give our teams reasons to believe in our ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact.
SummaryAs part of the continued evolution of our Global Pharmacovigilance organization, we are looking for a Global Pharmacovigilance Risk Minimization Physician to join our Therapeutic Dermatology (TD) team in Barcelona.
This role will be responsible for leading key post-marketing safety activities for Galderma's approved TD products, with a primary focus on Nemluvio (nemolizumab) but also including additional TD products. The position will play a critical role in ensuring continuous benefit-risk assessment, maintaining regulatory compliance, and supporting the safe use of our innovative therapeutic dermatology treatments worldwide.
The successful candidate will combine strong medical expertise, pharmacovigilance knowledge, and global stakeholder management skills to provide scientific leadership throughout the product lifecycle.
Key ResponsibilitiesPost-Marketing Safety and Risk ManagementLead ongoing benefit-risk assessments for assigned TD Galderma products, ensuring appropriate identification, evaluation, and management of safety risks.
Provide medical expertise for post-marking safety activities, with primary responsibility for Nemluvio and support for additional TD products.
Lead signal detection, validation, evaluation, and escalation activities using safety data, including individual case safety reports and aggregate safety information.
Develop and maintain Risk Management Plans (RMPs) and support implementation of risk minimization strategies across global markets.
Provide medical input into safety analyses, aggregate reports and relevant safety documentation throughout the product lifecycle.
Regulatory Compliance and Inspection ReadinessEnsure compliance with global pharmacovigilance regulations and internal safety standards.
Support the preparation for regulatory authority inspections and act as a subject matter expert during audits and inspections.
Maintain inspection readiness by ensuring appropriate oversight of PV processes, controlled documentation, SOPs, and work instructions.
Support the development and implementation of Corrective and Preventive Actions (CAPAs) following inspections or quality assessments.
Contribute to maintaining a robust Pharmacovigilance Quality Management System (QMS).
Scientific Leadership and Cross-Functional CollaborationAct as a medi#J-18808-Ljbffr
