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 affiliates, vendor, and Vendor Oversight Manager in relation to Global Outsourcing of local PV activities.o Ensure timely onboarding of affiliate staff (LPS Coordinators / Managers)o Ensure / contribute to development and maintenance of LPS relevant documents, incl LPS oversight plans and procedureso Ensure oversight of vendor performance, incl. review of monthly reports, participation in Quarterly Review and Trending meetings, review of documentation, and performance of spot checkso Ensure oversight of affiliate performanceo Ensure / contribute to oversight of affiliate and vendor (incl. subcontractor) project-relevant procedural documents and related deviations, incl. annual review of documentsAct as Team Lead for the LPS Support team, including:o Take ownership and responsibility for deliverableso Ensure execution (incl. coordination / management) of operational activitieso Proactively seek advice with relevant stakeholders (within and outside own organisation)o Provide mentoring of / sparring with / feedback to team members o Provide feedback to line managero Act as role model for team members on Lundbeck behaviours collaborates, customer focus, agile mindset

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 affiliates, vendor, and Vendor Oversight Manager in relation to Global Outsourcing of local PV activities.o Ensure timely onboarding of affiliate staff (LPS Coordinators / Managers)o Ensure / contribute to development and maintenance of LPS relevant documents, incl LPS oversight plans and procedureso Ensure oversight of vendor performance, incl. review of monthly reports, participation in Quarterly Review and Trending meetings, review of documentation, and performance of spot checkso Ensure oversight of affiliate performanceo Ensure / contribute to oversight of affiliate and vendor (incl. subcontractor) project-relevant procedural documents and related deviations, incl. annual review of documentsAct as Team Lead for the LPS Support team, including:o Take ownership and responsibility for deliverableso Ensure execution (incl. coordination / management) of operational activitieso Proactively seek advice with relevant stakeholders (within and outside own organisation)o Provide mentoring of / sparring with / feedback to team members o Provide feedback to line managero Act as role model for team members on Lundbeck behaviours collaborates, customer focus, agile mindset

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• Work collaboratively in the matrix organization with other Global Safety functions in supporting the affiliates and other local entities working on behalf of LEO• Contribute to the regular Global Safety meetings with the SCPsLocal pharmacovigilance requirementsPV Quality Documents• Lead the implementation and maintenance of a harmonized PV process across the affiliates and other local entities working on behalf of LEOAudits, Inspections and deviations• Coordinate Global Safety support before, during and after local audits/inspections• Global Safety management and oversight of local deviation reports• Global Safety management and oversight of local CAPAs Compliance • Compilation and management of data and documents for Global Safety compliance monitoringEnable the business• Support the EU QPPV in providing QPPV/PSMF documents for renewals as required locally• Provide PV training support and guidance to local safety persons at LEO affiliates, including development and maintenance of training material, etc.Relations• Contribute to the GS overall strategy goal of improving the communication and collaboration with the safety responsible persons in the affiliates and regions, this includes arranging regular meeting, e.g. monthly virtual meetings and biannual physical meetings in collaboration with other stakeholders

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 across LEO Pharma to actively encourage patient and product safety.Role and Responsibilities:• 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• Provide PV training support and guidance to local safety persons at LEO affiliates• Contribute to PV standard operating procedures writing and maintenance• Contribute to the development and continuous improvement of Pharmacovigilance quality and compliance management processes

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.• Audit and Inspection Subject Matter Expert• Audit and Inspection readiness within GS • Coordination and participation in all support related to health authority inspections in affiliates• Coordination of and participation in audits and inspections in GS• Timely closure, follow up, documentation and filing of audit and inspection findingsMain results: I provide successful problem solving in affiliates. I provide and present accurate and always timely trending and analysis of all global audit and inspection results to GS management. I am responsible for the overall coordination of health authority inspections in HQ and affiliates.

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 through: • 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 reference group with aim to make the cooperation between HQ and affiliate run smoothly. Supported the merger of the Nycomed and the Takeda PV system. Strong support of affiliates in all areas relating to PV audits. Successful problem solving in affiliates following poor audit or inspection results.

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. • Cooperated in the handling of safety requests from partners and affiliates. Main results: Full participation in all levels of the ICSR and AE case handling. Supported the merger between the Nycomed and the Altana Pharma PV systems by being involved in the creation and rolling out of new PV procedures for the affiliates.

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.

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.

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.

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.

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