Country: Germany
Functional area: Pharmacovigilance
Pharmacovigilance Manager

Carbyne has partnered with a European publicly listed, clinical stage biotech company with exciting immuno-oncology pipeline to search & select a Pharmacovigilance Manager to support their global clinical development program.

The role can work remotely 100% home-based anywhere in Europe with limited amount of travelling in the future. Ideally candidates should be based either in Germany or one of the CEE countries (Hungary, Czechia, Poland).

The purpose of the role is to provide pharmacovigilance oversight for oversee pharmacovigilance the company’s fully outsourced clinical trials.

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 uploadyour CV and we will get in touch with you for confidential discussion.
Pharmacovigilance Manager

Carbyne has partnered with a European publicly listed, clinical stage biotech company with exciting immuno-oncology pipeline to search & select a Pharmacovigilance Manager to support their global clinical development program.

The role can work remotely 100% home-based anywhere in Europe with limited amount of travelling in the future. Ideally candidates should be based either in Germany or one of the CEE countries (Hungary, Czechia, Poland).

The purpose of the role is to provide pharmacovigilance oversight for oversee pharmacovigilance the company’s fully outsourced clinical trials.

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.

clinical research