(Scientific Support) Compliance & PV, Associate Director, Italy

Job description

Pleased to meet you, we are Galapagos, a dynamic fast growing Biotech company with offices in Europe in Belgium (Mechelen), France (Romainville + Paris), the Netherlands (Leiden), Switzerland (Basel), Italy (Milano), Spain (Madrid), UK (London), Germany (München), and in US, Boston.

We’re in the business of changing lives. In our quest to discover and develop life-improving medicines we go where no one has ever gone before. In every challenge we face, we see new opportunities. We want to challenge the impossible. We need thought leaders and rapid thinkers, entrepreneurs in spirit and status quo-fighters. Collaborative innovators and perseverant idealists. We need the best-in-class. In other words, we need you: The ‘make-it-happeners’.

We are looking for our first Compliance and Pharmacovigilance Manager in Italy, Milan! Are you ready to conquer the world and make it happen with us?

Scope of the job

A Compliance and Pharmacovigilance Manager is responsible for ensuring Galapagos company's policies and procedures comply with regulatory and ethical standards. The Compliance and PV Manager is in charge to perform regular audits, implement company policies, design control systems, build and maintain the Pharmacovigilance departmental documentation, by handling and ensuring the pharmacovigilance related information flow.

Your role:

  • Develop and implement company policies and regulations
  • Design and monitor control systems to deal with violations of legal rules and internal policies
  • Regularly assess the efficiency of control systems and recommend effective improvements
  • Review and evaluate company procedures and reports to identify hidden risks or common issues
  • Perform periodic audits on company procedures and processes
  • Lead employee training sessions on legal and compliance issues
  • Assist the business development and client capabilities as needed
  • In collaboration with the Quality & Compliance Global Group, create the PV documentation and ensure that operational Pharmacovigilance processes and documents are respected and reflected in the Quality Management System, according to the operational model at Galapagos
  • Oversee all business operations relating to Compliance and Pharmacovigilance including policies, investments, and procedures (purchase order, invoices, payment milestones, etc.)
  • Ensure that study-specific and compound Safety documents are available across the portfolio and are appropriately filed
  • Contribute to the creation and the regular update of specific Pharmacovigilance related documents, such as Pharmacovigilance System Master File (PSMF), DSUR tracking etc., ensuring the Pharmacovigilance needs are met
  • Contribute to organize and co-chair different Departmental or cross-functional regular or “ad hoc” meetings

Job requirements

  • Bachelor’s Degree, preferably in Life Sciences, Business Administration or relevant professional experience in Pharmacovigilance, Compliance, accounting, finance, law
  • 4-6 years pharmaceutical industry strong Compliance and Pharmacovigilance experience
  • Ability to recognize risk and develop workable strategies to mitigate such risk
  • Excellent business judgment and strategic thinking
  • Able to work independently in a fast-paced, dynamic organization
  • Experience working in a global matrix environment
  • Excellent business judgment and strategic thinking
  • Proficiency in Microsoft Office is required (e.g., Word, PowerPoint, Visio, Excel)
  • Notion of general drug development process
  • Notion of Pharmacovigilance regulations, processes and systems within a drug development environment
  • Notion of ICH (International Council on Harmonization of Technical Requirements), GCP (Good Clinical Practice) and other Regulatory requirements applicable in the Pharmacovigilance domain
  • Knowledge of reporting procedures and record keeping
  • Fluency in English is a must