Eva Widebæk Rasmussen Email & Phone Number

Copenhagen, DK

Copenhagen, DK

København Og Omegn

København Og Omegn

Head of the safety department and overall responsible for safety surveillance, signal detection and risk management activities/processes during drug development and post-marketing.

København Og Omegn

Transformed the department from consultant led operational activities to internal led with focus on the evaluation of the safety profile of Y-mAbs products.- Led development of product safety monitoring and risk management- Lead of Data Monitoring Committees (DMCs) and chairing the internal Safety Committees - Part of the BLA team for naxitamab (GD2.

Headhunted from Genmab to build a safety department in Y-mAbs, maintain drug safety expertise, develop, and execute drug safety oversight for Y-mAbs products. - Interaction with a Clinical Research Organisation (CRO) on outsourcing of safety deliverables- Evaluation of important safety signals and associated responses to regulatory authorities- Established.

Copenhagen, Capital Region, Denmark

- Safety representative for two oncology products in early development- Responsible for surveillance, signal detection, and introduction of risk mitigation activities- Leadership of the Safety Committees - Interactions with the DMCs- Investigator meeting presentations - Authored/reviewed trial related documents e.g. annual reports, IBs, study protocols.

Copenhagen, Capital Region, Denmark

Involved in the outsourcing of safety operation activities to a CRO. Responsible for:- Medical evaluation of AEs- Surveillance of summarized safety data, signal detection, risk mitigation activities- Interactions with the Data Monitoring Committees (DMCs) and leading Safety Committee meetings - Training activities for investigators, CROs - Review of eCRF.

Copenhagen, Capital Region, Denmark

Worked with early clinical development of antibody-based drug candidates for the treatment of patients with cancer (among others; B-cell chronic lymphocytic leukemia (targeted towards CD20 receptors), head & neck-, lung- and colon cancer (targeted towards EGR receptors), multiple myeloma (targeted towards CD38 receptors), metastatic cervical cancer.

Copenhagen, Capital Region, Denmark

Data entry and medical evaluation of adverse events from clinical trials within the therapeutic areas of diabetes, haemostasis, growth hormone, haemophilia in addition to post-marketing and literature cases. Submission of SUSARs to regulatory authorities, reconciliation, presenter at CRA training and investigator meetings and participated in FDA inspection.

Master Of Science - Ms, Pharmacovigilance

Thesis: Safety Management of Investigator Initiated Trials including those involving Orphan Drugs Modules: - Labeling and Risk Management.

Information Technology

The Company Decision Analysis

Empirical Economy And Method

Business/Managerial Economics

Registred Nurse

Exam In The Medicines Act