Global Pharmacovigilance Risk Minimization Physician - Therapeutic Dermatology (Barcelona)

Global Pharmacovigilance Risk Minimization Physician - Therapeutic Dermatology (Barcelona)

04 ago
|
Galderma
|
Barcelona

04 ago

Galderma

Barcelona

ph3Global Pharmacovigilance Risk Minimization Physician - Therapeutic Dermatology /h3h3Location: Barcelona, Spain /h3pAt Galderma, we're unique and we embrace difference.br/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. /ppAt 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. /ph3Summary /h3pAs part of the continued evolution of our Global Pharmacovigilance organization, we are looking for a bGlobal Pharmacovigilance Risk Minimization Physician /b to join our Therapeutic Dermatology (TD) team in Barcelona. /ppThis role will be responsible for leading key bpost-marketing safety activities /b for Galderma's approved TD products, with a primary focus on bNemluvio (nemolizumab) /b 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. /ppThe successful candidate will combine strong medical expertise, pharmacovigilance knowledge, and general stakeholder management skills to provide scientific leadership throughout the product lifecycle. /ph3Key Responsibilities /h3h3Post-Marketing Safety and Risk Management /h3pLead ongoing benefit-risk assessments for assigned TD Galderma products, ensuring appropriate identification, evaluation, and management of safety risks. /ppProvide medical expertise for post-marketing safety activities, with primary responsibility for Nemluvio and support for additional TD products. /ppLead signal detection, validation, evaluation, and escalation activities using safety data, including individual case safety reports and aggregate safety information. /ppDevelop and maintain Risk Management Plans (RMPs) and support implementation of risk minimization strategies across global markets.



/ppProvide medical input into safety analyses, aggregate reports, and relevant safety documentation throughout the product lifecycle. /ph3Regulatory Compliance and Inspection Readiness /h3pEnsure compliance with global pharmacovigilance regulations and internal safety standards. /ppSupport preparation for regulatory authority inspections and act as a subject matter expert during audits and inspections. /ppMaintain inspection readiness by ensuring appropriate oversight of PV processes, controlled documentation, SOPs, and work instructions. /ppSupport the development and implementation of Corrective and Preventive Actions (CAPAs) following inspections or quality assessments. /ppContribute to maintaining a robust Pharmacovigilance Quality Management System (QMS). /ph3Scientific Leadership and Cross-Functional Collaboration /h3pAct as a medical and scientific partner across functions including Clinical Development, Medical Affairs, Regulatory Affairs, Quality, Commercial, and other global stakeholders. /ppRepresent Global Pharmacovigilance in relevant governance forums, safety committees, and cross-functional working groups. /ppCommunicate complex scientific and safety concepts clearly to both technical and non-technical audiences. /ppProvide scientific guidance and confidently challenge stakeholders when required to ensure patient safety and regulatory compliance. /ppBuild effective relationships with internal teams and external partners across global markets, including collaboration with international business partners. /ph3Continuous Improvement and Operational Excellence /h3pIdentify opportunities to improve pharmacovigilance processes, increase efficiency, and strengthen ways of working. /ppSupport initiatives related to automation, process optimization, and reduction of operational complexity.



/ppPromote a proactive safety culture focused on continuous improvement and patient protection. /ph3Skills and Qualifications /h3pbMedical Degree (MD or equivalent) required. /b /ppMinimum b10 years of experience within the pharmaceutical industry /b, with significant experience in bglobal /b positions within Global Pharmacovigilance and post-marketing safety. /ph3Strong expertise in: /h3ulliSignal detection and safety surveillance. /liliGlobal pharmacovigilance regulations and compliance requirements. /liliExperience working with bbiologics /b and understanding of their safety monitoring requirements. /liliDemonstrated experience supporting regulatory inspections, inspection readiness activities, Quality Management Systems (QMS), and CAPA management. /liliProven experience working in a bglobal environment /b, collaborating across regions. /liliExperience with dermatology, immunology, or other specialty therapeutic areas is highly desirable. /liliStrong communication, influencing, negotiation, and stakeholder management skills, with the ability to confidently challenge and align with senior colleagues. /liliAbility to work independently, manage complexity, and operate effectively in a changing and dynamic environment. /liliProactive, agile, and solution-oriented mindset with strong ethical standards and professional integrity. /li /ulh3What we offer in return /h3pAt Galderma, you will have the opportunity to contribute to the safety strategy of innovative dermatology treatments and make a meaningful impact on patients worldwide. You will work in a collaborative global environment where scientific excellence, innovation, and patient safety are at the heart of everything we do. /ppWe offer a hybrid working model, professional development opportunities, and the opportunity to grow within a leading global dermatology organization. /ph3Our people make a difference /h3pAt Galderma, you'll work with people who are like you - and people who are different. We value what every member of our team brings. Professionalism, collaboration, scientific curiosity, and a supportive ethos create the perfect environment for people to thrive and make a real impact. /p /p #J-18808-Ljbffr

📌 Global Pharmacovigilance Risk Minimization Physician - Therapeutic Dermatology (Barcelona)
🏢 Galderma
📍 Barcelona

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