Global PV Risk Minimization Physician

Global PV Risk Minimization Physician

Galderma

Uppsala, Sweden

As part of the continued evolution of our Global Pharmacovigilance organization, we are looking for a Global PV Risk Minimization Physician to join our Injectable Aesthetics (IA) team in Uppsala, Sweden.

This role will be responsible for leading key post-marketing safety activities for Galderma’s approved IA/medical device products, with a primary focus on the dermal filler and biostimulator portfolio but also including additional IA/medical device products as needed.

The position will play a critical role in ensuring continuous benefit-risk assessment, maintaining regulatory compliance, and supporting the safe use of our innovative IA treatments worldwide.

The successful candidate will combine strong medical expertise in class III medical devices intended for the aesthetic use, device vigilance knowledge, and global stakeholder management skills to provide scientific leadership throughout the product lifecycle.

Key Responsibilities

Post-Marketing Safety and Risk Management

• Provide medical expertise for safety surveillance, signal detection, and risk management activities;
• Conduct medical review of incident reports and evaluate emerging safety data from individual cases and aggregate analyses;
• Lead the scientific review of safety information in IFUs and other product labeling, signal evaluation reports, Periodic safety update reports (PSURs), and other aggregate safety reports, as applicable based on national regulatory requirements;
• Develop and maintain the product risk management file and associated documentation;
• Contribute to aggregate safety reports, Clinical Evaluation reports, and risk minimization strategies and benefit-risk evaluations;
• Coordinate global risk minimization activities associated with product use and support implementation across countries and verification of effectiveness;
• Validate and evaluate safety signals, ensuring timely escalation through appropriate governance processes.

Regulatory Compliance and Inspection Readiness

• Support responses to safety-related questions from Health Authorities and Competent Authorities;
• Contribute to regulatory submissions and maintenance of marketing authorizations;
• Ensure compliance with global device vigilance requirements and internal quality standards;
• Support audits, inspections, CAPA activities, and inspection readiness efforts.

Scientific Leadership and Cross-Functional Collaboration

• Partner with Clinical Development, Clinical Sciences, Medical Affairs, Regulatory Affairs, and Global Business Units and Operations on scientific and medical assessments.
• Contribute to safety governance forums;
• Support safety communications, scientific publications and interactions with Key Opinion Leaders;
• Contribute to due diligence activities and safety evaluations for business development opportunities;
• Communicate complex safety topics clearly and effectively to diverse stakeholders.

Continuous Improvement and Operational Excellence

• Drive process improvements and support initiatives that enhance the effectiveness and efficiency of device vigilance and risk management activities;
• Foster a proactive culture of patient safety, compliance, and continuous improvement.

Skills and Qualifications

Education

• Medical Doctor (MD) required;
• Additional qualifications in Clinical Pharmacology, Pharmaco/materio-vigilance and Drug Safety, Public Health, Epidemiology, or Biomedical Engineering are advantageous.

Experience

• Minimum 15 years of experience in global positions within medical device companies operating internationally;
• Significant experience across materiovigilance, medical device risk management and other post-marketing activities;
• Strong medical expertise in signal detection, safety surveillance, risk minimization and benefit-risk assessment, and global medical device regulations;
• Experience interacting with Notified Bodies and Health Authorities in the US, EU, and other regions regarding safety-related matters;
• Knowledge of epidemiology, statistics, and safety data evaluation;
• Proven ability to lead complex projects, identify risks, and drive cross-functional deliverables within a matrix environment.

Personal Qualities

• Excellent communication, collaboration, and stakeholder management skills;
• Strong scientific judgment and analytical mindset;
• High ethical standards and commitment to compliance and integrity;
• Ability to work independently and effectively in a dynamic global environment;
• Proactive, adaptable, and solution-oriented.

Languages

• Fluent written and spoken English;
• Additional languages, including Swedish, are considered an advantage.