Peter H. Eriksen Email & Phone Number

Bagsvaerd

Hatfield, England, United Kingdom

MSc Pharmacovigilance

Primarily worked with Pharmacovigilance in clinical trials. Trial set-up, protocol input/review, SAE handling including SAE reconciliation, AE review, Blinded Data review Meetings (BDRM) preparation and participation. Responsible for signal detection in allocated trials, CRO contact, CRA/Investigator trainingEvent adjudication set-up and conduct (Major Adverse Cardiovascular Events - MACE)Analyse pharmacovigilance data and ongoing safety surveillanceTrials covering e.g. COPD, RA, SLE, and cancer painTrials exploring biologics (Veltuzumab, Namilumab) in phase I and IIMedDRA coding specialist/reviewer/trainerReviewer of pharmacovigilance-, data management-, and cross functional SOPsTraining/coaching of colleagues internally and externally (LIF),Database cleaning and migration in connection to mergersResponsible for identifying and defining appropriate actions on new safety signals in +300 marketed products via monthly ADR reviewIn connection to company merger (Takeda acquired Nycomed) been actively participating in defining work cultures, new pharmacovigilance processes and collaboration cross regions.

Primarily worked with Pharmacovigilance in Clinical trials: Trial set-up, protocol input/review, SAE handling including SAE reconciliation, AE review, Blinded Data review Meetings (BDRM) preparation and participation. Responsible for signal detection in allocated trials, analyse pharmacovigilance data and ongoing safety surveillance.CRO contact, CRA/Investigator training.Trials covering e.g. COPD, RA, SLE, acute and cancer painTrials exploring biologics (Veltuzumab, Namilumab) in phase I and IIMedDRA coding specialist/reviewer/trainerReviewer of pharmacovigilance-, data management-, and cross functional SOPs, Training/coaching of colleagues internally and externally (LIF),Responsible for identifying and defining appropriate actions on new safety signals in +300 marketed products via monthly ADR review until March 2013.Recruitment of new staffIn connection to company merger (Nycomed acquired Altana) been actively participating in defining work cultures, new pharmacovigilance processes and collaboration cross regions.

Half time Clinical Trials - half time Post Marketing PharmacovigilancePost Marketing and clinical trial ICSR handlingClinical Trials: SAE handling, trial set-up, protocol input/review, CRA/investigator training, signal detection, AE review, MedDRA coding specialist/reviewer, responsible for signal generation, SAE reconciliation, CRO contact. Writing and reviewing Clinical Safety documents for regulatory submissionClose cooperation with internal shareholders e.g. QA, Medical, Data Management, Data Science.Trials covering e.g. COPD, acute and cancer painPost Marketing: Approving cases, analysis of pharmacovigilance data and ongoing safety surveillance.Core member in several Safety Management Teams (SMT)/Global Safety Teams (GST) with responsibility of signal detection by reviewing ADRs, SAEs, and AEs. Created signal workups and changes to reference safety information. SMT/GSTs including both clinical development programs and post marketing lifecycle management.Training/coaching of colleagues internally and externally (LIF),Close cooperation with external shareholders e.g. Investigators, CROs, and vendors

Primarily Post Marketing PharmacovigilanceAll steps in Post Marketing ICSR handling including assessment and MedDRA codingData retrieval from safety databaseData clean-up in connection to migration of safety databases

Intensive Care Unit for children and adults

C 2123

Gastrointestinal department with emergency and semi intensive obligations.

D 733

Gastrointestinal surgery.

Msc Pharmacovigilance, Msc Pharmacovigilance

Activities and Societies: 2013: Management Of Pharmacovigilance Data (15 ECTS) 2013: Spontaneous Reporting And Adverse Drug Reactions.

Pgcert In Pharmacovigilance

Icu Nurse, Intensive Care Unit Specialist

Diploma In Sports And Health Massage & Treatments

Nurse