Pharmacovigilance Expert

Carbyne has partnered with a European publicly listed, clinical-stage biotech company with an exciting immuno-oncology pipeline to select a Pharmacovigilance Expert to support their global clinical development program. The purpose of the role is to provide oversight for the company’s fully outsourced clinical trials.

The ideal candidate should be located in Germany, Hungary, Poland, France, or the UK. Candidates must have the legal right to work in their respective country of residence.

Responsibilities:

• Oversee global clinical safety reporting activities and develop processes on the Sponsor side as appropriate.
• Ensure PV compliance with global regulations and industry best practices throughout all activities like safety date review, risk management and signal detection with all stakeholders and collaboration partners.
• DSUR assembly and review.
• Oversight of PV service provider ...