Medical Safety Officer

Organization:

Akkodis is a global digital engineering company and Smart Industry leader. We enable clients to progress in their digital transformation with Talent, Academy, Consulting and Solutions services. Our 50,000 experts combine best-in-class technologies, R&D and deep industry knowledge for targeted innovation. We are passionate about building a smarter future together. Within Akkodis, we are looking for a Medical Safety Officer for one of our clients in the region of Mechelen.

Main Purpose of Position: Reporting to the Medical Safety Manager, the Medical Safety Officer is the primary liaison for the organization's global pharmacovigilance efforts for our investigational product portfolio. Responsibilities include ensuring operational compliance in clinical trials, overseeing pharmacovigilance vendors and contributing to pharmacovigilance compliance.

Key Responsibilities:

• Oversee compliance with operational pharmacovigilance processes in assigned projects.
• Collaborate with external service providers to process individual clinical study safety reports (ICSRs) and ensure that expedited reporting requirements are met.
• Coordinate the development of study-specific safety project plans for assigned clinical trials and oversee their implementation.
• Manage the development and submission of safety update reports (DSURs).
• Ensure compliance with regulatory requirements and timely submission of expedited and periodic reports.
• Oversee the pharmacovigilance portion of the electronic Trial Master File (eTMF) in collaboration with Clinical Operations.
• Collaborate with Quality Management to ensure operational processes are aligned with the organization's operational model.
• Collaborate with external service providers to ensure that pharmacovigilance services meet industry standards and regulatory guidelines.
• Contribute to the preparation and review of safety related documents for clinical trials.
• Represent the Medical Safety Department in cross-functional meetings or working groups as needed.

Job requirements:

• Pharmacist, or a Life Sciences degree
• 3+ 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.
• 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