Medical Safety Leader - Romainville

Job description

Galapagos (Euronext & NASDAQ: GLPG) is a clinical-stage biotechnology company specialized in the discovery and development of small molecule medicines with novel modes of action. Our pipeline comprises Phase 3, 2, 1, pre-clinical and discovery studies in cystic fibrosis, inflammation, fibrosis, osteoarthritis and other indications.  We have discovered and developed filgotinib: in collaboration with Gilead we aim to bring this JAK1-selective inhibitor for inflammatory indications to patients all over the world.  Galapagos is focused on the development and commercialization of novel medicines that will improve people’s lives. The Galapagos group, including fee-for-service subsidiary Fidelta, has approximately 480 employees, operating from its Mechelen, Belgium headquarters and facilities in The Netherlands, France, and Croatia.  More information at www.glpg.com.

 

We are looking for a

 

Medical Safety Leader

M/F fulltime permanent contract

 

Description

 

Under the direction of the Head of Department, the Pharmacovigilance Manager is responsible for the global pharmacovigilance for Galapagos investigational products, including :

- review and analysis of safety data from non-clinical and clinical trials,

- quality control of ICSRs,

-identification and investigation of safety signals,

- management of benefit-risk profile for assigned compounds,

- implementation of PV processes and scientific review of internal and external documents.

May represent the Pharmacovigilance Department at internal and external meetings, as well as work with the Medical Compound Lead as medical support for Safety issues.

The Pharmacovigilance Manager will interact with multiple internal and external stakeholders in the medical community as well with regulatory authorities and vendors.

 

Your principal accountabilities will be :

1.      Ensure that, in collaboration with the Quality & Compliance Group, 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 ICSR’s from ongoing clinical studies and collaborate with external service provider to process the ICSR; ensure expedited reporting requirements are met

5.      Review study-specific Safety Plan for each clinical study 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 PV Department in some cross-functional meetings or working groups, concerning administration, documentation, process implementation or financial topics

 

 

 

Requirements

Profile

 

Education

The successful candidate has a Medical Doctor degree.

 

Experience and skills

  • 3-5 years 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
  • 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
  • Excellent writing and communication skills both towards team members within the company as towards external contacts
  • Fluent in English 

 

At Galapagos we aim to recruit the best people, who stand out among their peers, with integrity and excellent interpersonal and organizational skills. Our employees are the strength behind Galapagos, a highly motivated team, eager to maintain Galapagos’ leading position and achieve breakthroughs in pharmaceutical research. Galapagos offers a competitive remuneration package and a dynamic work environment.