Jens Kramer Molbech Odgaard Email & Phone Number

Copenhagen, DK

Valby, Denmark

Leading proactive and strategic establishment, development and maintenance of activities related to Local Patient Safety Support, including:o Acting as primary contact point for affiliates and Global Outsourcing vendoro Daily management of LPSSupport mailbox, incl. handling of queries in a timely mannero Drive continuous interaction with and support to.

Valby, Denmark

Leading proactive and strategic establishment, development and maintenance of activities related to Local Patient Safety Support, including:o Acting as primary contact point for affiliates and Global Outsourcing vendoro Daily management of LPSSupport mailbox, incl. handling of queries in a timely mannero Drive continuous interaction with and support to.

Copenhagen, Capital Region, Denmark

• The primary focus of my Quality and Compliance Specialist role is to
• Support the development of one global pharmacovigilance system at the LEO.
• Participate in- and support Global Safety improvement projects My area of responsibilities include:To manage contracts with the affiliates
• Maintain the PV contracts with the affiliates
• Manage Safety Contact Person (SCP) related input to the PSMFResponsible for building the bridge between global and local pharmacovigilance
• Be a point of contact for the affiliates and other local entities working on behalf of LEO for request related to the PV system

Copenhagen Area, Denmark

• As Senior Safety Training Professional with LEO Pharma my overall objective is To communicate awareness and understanding of PV regulations and PV procedures in the global PV organisation and to relevant stakeholders.
• To assume responsibility and tasks related to PV Training Management as described in Global Pharmacovigilance QMS documents
• Design, develop, coordinate and maintain training materials reflecting current Pharmacovigilance requirements and target audience qualifications
• Plan and deliver Pharmacovigilance training sessions to relevant LEO employees outside the Pharmacovigilance organisation
• Set and maintain global Pharmacovigilance training standards and effectiveness measures in alignment with QPPV expectations
• Support GPV subject matter experts in scoping content and setting learning objectives

Copenhagen Area, Denmark

• Safety compliance Specialist with special focus on pharmacovigilance audits and inspections. This encompasses the overall responsibility for the below areas
• For cause visits with affiliates in case of system failure or acute PV related problems
• Training of GS and affiliate employees in all subjects related to compliance and audit/inspection.
• Responsible for writing of audit and inspection related procedures (SOPs)
• Audit and inspection relevant documentation for the Pharmacovigilance System Master File
• Accurate trending of all global audit and inspection findings including necessary suggestions for system updates to prevent these.

Roskilde Denmark

• In this job is has been my responsibility to make the cooperation between affiliate PV and head quarter PV work, so that affiliate PV becomes an integrated part of head quarter PV. This has been successfully achieved.
• PV support visits in affiliates, both for acute problem solving, training and to Support implementation of a local PV system.
• Maintenance of Local PV-SOPs and templates.
• Organizing and conducting the yearly Global Drug Safety Officer (DSO) meeting.
• Head of the Drug Safety Officer (DSO) Reference Group.
• Audit and inspection support: pre, on site, and post audit (including CAPA-plan responses) in more than 26 affiliatesI have had 60 – 70 travelling days a year.Main results: Served as the head of the affiliate PV.

Nycomed Pharma

• In this job, I was responsible for the daily individual case safety report handling, and in addition the following:
• Evaluation of scientific literature.
• Searches in the Nycomed drug safety database.
• Pharmacovigilance L-SOP template for affiliates.
• Writing of aggregate reports.
• Signal detection and safety management team participation.

Pg Diploma With Commendation, Pharmacovigilance, Pharmacovigilance

Qms Auditor/ Lead Auditor - Passed Written Exam

Has participated in the QMS Auditor/ Lead Auditor training course and passed the written examination and continuous assessment necessary.

Module In Pharmacovigilance Pgd, Spontaneous Reporting And Adverse Drug Reactions In Special Groups

Learning Outcomes: Depth and systematic understanding of the source and optimum composition of spontaneous reports * have depth and.

Module In Pharmacovigilance Pgd, Management Of Pharmacovigilance Data

Aims: To develop an understanding of key aspects of pharmacovigilance data management, with reference to Good Clinical Practice (ICH E6).

Module In Pharmacovigilance Pgd, Adverse Drug Reactions By Major Body Systems, Pharmacovigilance

The aim of this module is to enable an understanding of the pathophysiology and clinical presentation of adverse drug reactions in.

Module In Pharmacovigilance Pgd, Pharmacovigilance Regulations And Guidelines, Pharmacovigilance

Pharmacovigilance Regulations and Guidelines. The aims of this course was to enable an understanding of the European (including MHRA,).

Post Graduate Certificate, Pharmacovigilance

Module Of Pharmacovigilance Pgd, Principles Of Pharmacovigilance

Aim: The aim is to develop an understanding of the principles of pharmacovigilance from the development of the science to its place in the.

Module In Pharmacovigilance Pgd, Drug Safety In Clinical Trials

The aims of this module are to enable students to: To gain an understanding of the different phases of clinical studies, their relative.

Module Of Pharmacovigilance Pgd, Labelling And Risk Management, Pharmacovigilance

The aims of this course are to enable knowledge and understanding of the Regulations and industry practice concerning Labelling and Risk.

Managing Projects

Module In Pharmacovigilance Pgd, Pharmacoepidemiology

Aim: To develop an understanding of the types, validity, application and assessment of post-marketing safety data and methodologies in the.

Latest Developments In Parmacovigilance

Clinical Research And Gcp 2

Medical Approach In Diagnosis And Management Of Adrs

Safety & Pharmacovigilance 2

Certificate Of Basic Competence In Clinical Research And Gcp

Safety & Pharmacovigliance 1

Education record

Matematisk Studenter Eksamen