Medical Safety Operations consultant (Contractor)

Core Purpose of Role: Reporting to the Medical Safety Director, the Medical Safety Operations Consultant serves as the key liaison for Galapagos' global pharmacovigilance efforts across our portfolio of investigational products. Responsibilities include ensuring operational compliance and excellence in clinical trials, overseeing Pharmacovigilance vendors, and contributing to Galapagos' adherence to Pharmacovigilance regulations.

Key Responsibilities:

• Ensure adherence to pharmacovigilance operational processes in assigned projects.
• Collaborate with external service providers to process Individual Case Safety Reports (ICSRs) from clinical trials and ensure expedited reporting requirements are met.
• Coordinate the development of study-specific Safety Project Plans for assigned clinical studies and oversee their execution.
• Manage the development and submission of Development Safety Update Reports (DSURs).
• Ensure compliance with regulatory requirements and timely submission of expedited and periodic reports.
• Oversee the pharmacovigilance part of the electronic Trial Master File (eTMF) in collaboration with Clinical Operations.
• Collaborate with Quality Management to ensure operational processes align with Galapagos' operational model.
• Work with external service providers to ensure pharmacovigilance services meet industry standards and regulatory guidelines.
• Contribute to the creation and review of safety-related documents for clinical studies.
• Represent the Medical Safety Department in cross-functional meetings or working groups as needed.
  

Job requirements:
Education (add qualification if relevant) & experience:

• Pharmacist, or a Life Sciences degree
• 5+ years of experience in similar position, including experience with working in a structured environment as a member of program/compound teams and in general successful working in a matrix environment.
• PV inspection experience and leading corrective and preventive actions
• Experience in leading process improvement within Safety and cross functionally.
• Experience in drug development, in a biotech or pharmaceutical company
• Experience in a matrix environment, interaction with stakeholder with different background and ability to adapt to corporate culture are essential

General skills:

• Broad knowledge of pharmacovigilance needs within a drug development environment
• 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 against a tight deadline and in a demanding environment
• Very good technical and organizational skills
• Communication Skills
• Excellent writing and communication skills both towards team members within the company as towards external contacts
• Ability to negotiate and influence
  

Language Skills:

• Fluent in English, working knowledge of other international languages beneficial.