Associate Director – Safety Operations (12 month contract)

Associate Director – Safety Operations (12 month contract)

Location – Zurich Switzerland

Company –

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.

Required Experience

• Education
  • 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

Additional information:

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