Senior PV Associate Analytics and Reporting Specialist

hace 7 días

Madrid, Madrid, España Galderma A tiempo completo
About the Role

We are seeking a highly skilled Senior PV Associate Analytics and Reporting Specialist to join our team at Galderma. As a key member of our Pharmacovigilance department, you will be responsible for implementing pharmacovigilance plans, processes, and policies related to the collection, assessment, and prevention of adverse effects following the use of our marketed or development products.

Key Responsibilities
  • Product Safety Data Management: Reconcile, process, and communicate high-quality product safety data and analysis to internal and external stakeholders throughout the product life cycle.
  • Pharmacovigilance Program Implementation: Implement and execute pharmacovigilance programs and policies with rapid identification and analysis of safety signals to inform emerging product safety profiles of all product types and drive patient safety risk management.
  • Strategic Safety Expertise: Align and implement Pharmacovigilance plans and activities to provide integrated strategic safety expertise and safety deliverables to product development programs.
  • Quality Assurance: Administer relevant activities to control the quality and accuracy of the data used in product discovery and development programs.
  • Quality Documents and Audits: Prepare department quality documents and participate in quality audits and inspections.
Requirements
  • International PV Regulations: Comprehensive knowledge of international PV regulations, standards, and principles for drugs, cosmetics, and medical devices.
  • Aggregate Reporting and Risk Management: Good knowledge and extensive experience of aggregate reporting, risk management standards, and methodology and signal detection from the pharmaceutical/medical device industry.
  • Global Vigilance and Safety Requirements: Good knowledge of the global vigilance and safety requirements for clinical development and registration process.
  • Microsoft Office and PV Computerized Systems: Good knowledge of Microsoft Office suite of products and PV computerized systems.
What We Offer
  • Diversity and Inclusion: You will be working for an organization that embraces diversity and inclusion and believes we will deliver better outcomes by reflecting the perspectives of our diverse customer base.
  • Competitive Compensation Package: You will receive a competitive compensation package with bonus structure and extended benefit package.
  • Hybrid Work Culture: You will be able to work in a hybrid work culture.
  • Feedback Loops and Career Growth: You will participate in feedback loops, during which a personalized career path will be established.
  • Ownership and Accountability: You will be joining a growing company that believes in ownership from day one where everyone is empowered to grow and to take on accountability.

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