Associate Director – Safety Operations (12 month contract)
Location – Zurich Switzerland
A small-medium sized bio-pharmaceutical company focused within unmet medical needs in the rare disease space is looking to expand. They have grown 20% in the last year alone, across both the US and in Europe!
They have one product with both EMA and FDA approval, with more products coming through the pipeline.
The Role –
This position will be an integral part of the growing Safety Operations teams, working cross-functionally with multiple teams, in a highly visible role.
Summary of Key Responsibilities
- Provide vital support to the Clinical trials (I-III) in a Medical Safety Operations perspective, working closely with clinical development teams, investigators, CRA’s
- Responsible for Pharmacovigilance vendor oversight to ensure Individual Case Study Report management
- Responsible for interdepartmental collaboration, including Quality Assurance, Clinical Operations, Regulatory Affairs to ensure alignment on procedures, shared deliverables, and goals.
- Develop and review documents and procedures critical for the success of the clinical studies.
- Oversee and support aggregate safety reports development and submission.
- Address quality control activities such as deviation identification, documentation, and Corrective Action Preventative Actions (CAPA) management related to the PV processes.
- Support internal audits and regulatory inspections.
- Strong Scientific background – MD, PhD, PharmD
- Specific Background
- Experienced in managing multiple vendors
- Experience supporting Clinical Trials
- Ideally coming with a knowledge of the rare disease space
- Good knowledge of US, EU, and ICH guidelines
- Clinical study safety processing and reporting preferred
Remote working – 3-4 days a week working from home
Engagement – 12 month contract, full time, possibility of moving to move to full-time after this