Compliance & Pharmacovigilance Manager

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.

We are looking for a Compliance & Pharmacovigilance Manager.

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. This person will act as local single point of contact (SPOC) for global functions in Compliance, Pharmacovigilance and Quality Assurance, with a coordination role of Regulatory Affairs too.

Principal Accountabilities:

  • Monitor all applicable laws, regulations, and national Codes of Conduct to ensure full compliance of GxP-related activities
  • Develop and implement company policies and regulations
  • Design and monitor control systems to deal with violations of national 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
  • Support Finance & Global Compliance with the reporting of transfers of value (ToV) into the national transparency registers (Sunshine Act)
  • Lead employee training sessions on compliance and PV topics
  • In collaboration with the Quality & PV 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.)
  • Represent the company 24/7 as the local contact person for Pharmavovigilance (LCPPV)and operate in close collaboration with the EU QPPV; keep oversight of all PV related activities (AE reporting, aRMM implementation, Patient Support Programs (PSP), Market Research Programs (MRP), vendor oversight, local literature review, 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.

Working Relationships:

Reports to Country Medical Director. Works closely with Ethics & Compliance Global team and Global PV team. External relationships include vendors, outside counsel, industry peers, and government agencies.

Job requirements

Job requirements:

  • Bachelor’s Degree, preferably in Life Sciences, or relevant professional experience in Pharmacovigilance, Compliance, Quality, finance or law
  • 4-6 years pharmaceutical industry experience, with strong Compliance and Pharmacovigilance professional practice
  • Committed to combine business acumen with highest ethical standards, ensuring compliance with all applicable laws and company policies
  • Excellent organisation and coordination skills when dealing with complex projects; demonstrated solid problem-solving skills; result oriented
  • Ability to influence, negotiate, and effectively collaborate with other functions, including global regulatory affairs, compliance, commercial, quality and supply, pharmacovigilance and legal
  • Proficiency in Microsoft Office is required (e.g., Word, PowerPoint, Visio, Excel).

General skills:

  • High ethical standards, strong critical thinking, analytical, and problem-solving skills
  • Ability to drive initiatives without direct line management authority, to meet deadlines and set priorities, in a fast-paced, dynamic organization. Autonomous, self-motivated, and flexible with the ability to adapt quickly to change or shifting priorities
  • Must possess strong verbal, written, presentation, and other communication skills
  • Notion of general drug development process
  • Notion of Pharmacovigilance regulations, processes, and systems within a drug development environment. Good knowledge of PV related activities (AE reporting, aRMM, PSP, MRP, vendor oversight); experience as local contact person for pharmacovigilance (LCPPV) is preferred
  • 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
  • Fluency in local language is a prerequisite

Language Skills:

  • Fluency in English is a must
  • Fluency in local language is a prerequisite