Country: Europe
Functional area: Pharmacovigilance
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.
Responsibilities:
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 and CRO partners.
- Develop and maintain PV agreements with all vendors.
- Point of contact for PV related matters with all business partners.
- Life Science / Medical degree
- Pharmaceutical industry experience including at least 3-4 years in clinical safety arena
- Deep understanding of clinical drug development process
- Computer literacy
- Fluent English required
- Critical thinking and pro-active attitude
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 and CRO partners.
- Develop and maintain PV agreements with all vendors.
- Point of contact for PV related matters with all business partners.
Requirements:
- Life Science / Medical degree
- Pharmaceutical industry experience including at least 3-4 years in clinical safety arena
- Deep understanding of clinical drug development process
- Computer literacy
- Fluent English required
- Critical thinking and pro-active attitude
Should you be interested in the details of this vacancy please upload your CV and we will get in touch with you for confidential discussion.