Pharmacovigilance Manager

Job description

RMV 145

Under the directions of the Head of Department, the Pharmacovigilance Manager is responsible for the global pharmacovigilance activities across the  Galapagos investigational products portfolio. The Pharmacovigilance Manager will interact with multiple internal and external stakeholders in the medical community as well with regulatory authorities and vendors.


Responsibilities :
  1. Ensure that, in collaboration with the Quality & Compliance Group, the pharmacovigilance operational processes and roles are followed according to Galapagos operational model 
  2. Manage the external pharmacovigilance services providers, up to industry standards as per regulations and guidelines, including financial follow up, quality control of the ICSRs, DSURs and any other Safety related documents, compliance with regulatory requirements (timely submission of expedited and periodic reports
  3. Perform medical review and provide medical advice on safety-related aspects associated with the assigned compounds and Chair regular meetings of compound Safety profile review across the organization (Pre-Clinical Development, Clinical, Clinical Pharmacology…
  4. Evaluate/assess ICSRs from ongoing clinical studies and collaborate with external service provider to process the ICSRs; and to  ensure the expedited reporting requirements are met
  5. Review study-specific Safety Plan for clinical studies across the portfolio, and ensure oversight on activities executed in view of such Safety Plan
  6. Integrate the safety scientific component to build a strategic framework for clinical development plans
  7. Contribute to the creation and review of the Safety parts of certain clinical study related documents – Clinical Study Synopsys/Protocols, Clinical Study Reports, etc
  8. Contribute to the creation and review of the Safety parts of certain compound related documents – Investigator’s Brochure, dRMP, etc
  9. Collaborate with the Regulatory Lead to create and submit the Development Safety Update Report (DSURs)
  10. Upon request, deputize the Head of department, and represents the Medical Safety Department in some cross-functional meetings or working groups, concerning administration, documentation, process implementation or financial topic

Requirements

Education

The successful candidate has a Medical Doctor degree.


Experience
  • 3-5 years of experience in a Pharmacovigilance role for compounds in clinical development
  • Broad experience in drug development, in early as well as in late stage, in a biotech or pharmaceutical company
  • Project Management experience in a matrix environment and ability to adapt to corporate culture are essential

General Skills

  • Flexibility and ability to function across multiple disease areas Broad knowledge of pharmacovigilance needs within a drug development environment
  • Deep knowledge in Good Vigilance Practice (GVP)
  • Sound knowledge of general drug development process
  • Sound knowledge of ICH (International Council on Harmonisation of Technical Requirements), GCP (Good Clinical Practice) and other regulatory requirements applicable in the pharmacovigilance domain Excellent team player, able to deliver in a demanding environment
  • Good organizational skills

Communication Skills

  • Excellent writing and communication skills both towards team members within the company as towards external contacts 
  • Fluent in English