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Curriculum Vitae - Dr. med. Arne Erdmann

 

Personal Details

Date of Birth: 30.04.1964 in Leverkusen

Address: 

D – 82211 Herrsching am Ammersee

Mobile: +49 / (0)151 / 2405 4605

E-Mail: Arne.Erdmann@Klinfor.de

 

 

Employment history:

11.04.2022 - 31.07.2022                     Fresenius-Kabi, Switzerland

  • Pharmacovigilance Consultant

01.04.2021 – 30.11.2021                    Immunic, Gräfelfing

  • Medical Reviewer

 Medical review and co-ordination of finalization of a CSR in COVID-19

  • Head of Pharmacovigilance

Initiation of building up the pharmacovigilance department

 

01.04.2020 – 31.12.2020                    Morphosys, Planegg

  •    Medical Reviewer

Medical review of studies in diffuse large b-cell lymphoma

 

01.07.2019 – 31.12.2019                    Novartis, Basel

  • Medical Reviewer (part-time freelance position)

Medical Review for a Phase II study in transplantation

 

01.01.2019 – 31.08.2019                    Abbott,Hannover

       ●    Medical Safety Expert (part-time freelance position)

 Signal detection and Safety report writing for various drugs

 

01.08.2018 – 31.10.2021                    Bayer, Berlin

 

●    Medical Reviewer (part-time freelance position with variable FTE)

Medical review of study data in ophthamology

 

10.07.2012 – 31.12.2018 Novartis, Basel

  • Medical Reviewer (fulltime freelance position)

Medical review of 5+ international studies in transplantation

 

15.06.2009 – 18.05.2012 Astellas Pharma GmbH, München

  • Medical Advisor (in-house fulltime freelance position)

Management of international studies for Germany, Austria and Switzerland, budget responsibility and line manager for the involved study team.

  • Benign prostate hyperplasia, Phase III

  • Prostate cancer, Phase III

  • Invasive fungal infection prophylaxis in high risk patients receiving liver transplantation, Phase III

  • Pre-emptive invasive fungal infection therapy in high risk patients with peritonitis after abdominal surgery, Phase II

  • Clostridium difficile infection treatment in high risk immunocompromised patients, Phase III

 

01.10.2006 – 30.06.2009 Pharm-Olam International, München

  • Project Manager 01.10.2006 – 30.09.2008

Project Management including budget responsibility and line management for national and international studies, phase I and III, attending and presenting at investigator and bid defence meetings.

  • Lupus erythematosus, Phase III

  • Cat allergy, Phase I

  • Pneumonia, Phase III

 

  • Medical Monitor 01.10.2008 – 30.06.2009

Responsible for Medical Monitoring and Drug Safety of international studies phase II – III

  • NSCLC, Phase II

  • Rheumatoid arthritis, Phase II

  • Acromegaly, Phase III

 

 

01.07.2004 – 30.09.2006 UCB GmbH, Kerpen

  • Medical Scientific Advisor

Responsible for 12 investigator initiated studies conducted in Germany, regular contact to opinion leaders- indication was epilepsy, also giving scientific advice to investigators

 

03.02.2003 – 30.06.2004 MDS Pharma Services, Langenfeld

  • Project Manager

Project Management of international studies phase III

  • Onychomycosis, Phase III

  • Hand dermatitis, Phase III

 

  • CRA

Monitoring of national and international studies phase II and IV

  • CABG, Phase IV

  • Prostate cancer, Phase II

  • Renal failure, Phase IV

 

 

01.04.2002 – 30.04.2002 Viscum AG, Bergisch Gladbach

  • Medical Advisor

Protocol development for a phase I study

 

01.07.1996 – 31.03.2002Omnicare Clinical Research, Cologne

 

  • Medical Writer 01.07.1996 – 31.12.1996

Writing of 6 integrated study reports, 1 CRF and 1 Protocol

 

  • CRA

Monitoring of clinical studies phase II and IV, initiation and recruiting phase, maintenance of regulatory files, SAE reporting, attendance of investigator meetings

  • Erythropoesis, Phase IV

  • Hypertension, Phase II

  • Ovarian cancer, Phase II

  • NSCLC, Phase II

 

  • Project Manager 01.01.1997 – 31.07.1999

Project Management of national and international studies phase III:Effectively manage of all aspects of assigned clinical trials according to the specificities of the sponsor’s contract; Control project team activities to ensure ICH-GCP guidelines and SOPs are strictly observed, including study preparations, site initiations, periodic monitoring, status and safety reporting; Regularly meet and liaise with sponsor to ensure study conduct and completion are progressing according to sponsor needs and established study timelines; Coordinate all ancillary aspects of the study, including vendor management, data management, pharmacovigilance, statistician, and medical writer

  • Atrial fibrillation, Phase III

  • Artherosclerosis, Phase III

 

  • Safety Officer 01.08.1999 – 31.03.2002

Responsible for the Drug Safety of 6 studies phase II – III

 

 

 

Resident:

 

01/1996 – 06/1996 Rheinische Landes – und Hochschulklinik Düsseldorf (Psychiatry)

10/1994 – 09/1995 Private practice Dr. Storch, Düren (Nuclear medicine)

 

 

Civilian Service:

04/1984 – 02/1985 Mobile social service, „Arbeiterwohlfahrt“, Cologne

 

11/1983 – 03/1984 Home for the aged in Leverkusen

 

 

Therapeutic Experience:

 

Cardiovascular

Gastroenterology

Gynaecology

Immunology

Infectious diseases

Musculoskeletal

Nephrology

Neurology

Oncology

Psychiatry

Transplantation

 COVID 19

 

Education:

Dissertation:

 

1992 – 1998 University of Cologne, title: „Laserangioplasty of Peripheral Arteries“

(experimental work, “cum laude”)

 

Studies:

1985 – 1992 Human medicine (MD)

University of Cologne

Graduation: License to practice medicine

 

1970 – 1974 Primary school in Leverkusen

1974 – 1983 Secondary school in Leverkusen

Graduation: University-entrance diploma

 

 

 

Languages:

 

German – Mother tongue

English – Business Fluent

French – Good Knowledge

Spanish – Good knowledge

 

 

Memberships: Ärztekammer Bayern (Chamber of physicians)

Deutsche Gesellschaft für Pharmazeutische Medizin (DGPharMed)

 

 

Study Details Form:

 

Role on Study

(e.g. CRA, CPM etc.)

Indication

No. of patients

No. of sites

Countries involved

Services involved (e.g. full service or just clinical)

Stages of study involved (e.g. set up to end, just close-out etc.)

Medical Writer

Rejection prophylaxis

80

10

Germany

Integrated clinical study report

NA

Medical Writer

Burn

10

1

Germany

Integrated clinical study report

NA

Medical Writer

Helicobacter pylori infection

300

40

Germany

CRF-Design

NA

Medical Writer

Infertility

400

50

Germany

Integrated clinical study report

NA

Medical writer

Arthrosis

80

12

Germany

Protocol development

NA

Medical writer

Allergic rhinitis

70

8

Germany

Integrated clinical study report

NA

Medical writer

Allergic conjunctivitis

70

8

Germany

Integrated clinical study report

NA

Medical writer

Morbus Wegener

90

12

Germany

Integrated clinical study report

NA

CPM/CRA

Atrial fibrillation

1200

60

Germany, Czech republic

Full service

Set-up to recruiting

CRA

Erythropoesis

120

6

Germany

Full service

Set-up to recruiting

CRA

Hypertension

110

7

Germany

Full service

Set-up to recruiting

CRA

Ovarian cancer

100

5

Germany

Full service

Set-up to recruiting

CRA

NSCLC

100

8

Germany

Full service

Set-up to recruiting

CPM

Artherosclerosis

500

35

Germany

Full service

Set-up to recruiting

Safety Officer

Pneumonia

400

60

Germany

Full service

Set-up to end

Safety Officer

Schizophrenia

120

20

Germany

Full service

Set-up to end

Safety Officer

Torticollis

240

26

Germany

Full service

Set-up to recruiting

Safety Officer

Blepharopspasm

240

28

Germany

Full service

Set-up to recruiting

Safety Officer

COPD

220

23

Germany

Full service

Set-up to recruiting

Safety Officer

Small cell lung cancer

90

7

Germany

Full service

Set-up to end

 

CRA

 

CABG

110

8

Germany

Full service

Recruiting

CRA

Prostate cancer

85

7

Germany

Full service

Recruiting

CRA

Renal failure

240

12

Germany, Austria, Switzerland

Full service

Recruiting

CPM

Onychomycosis

220

11

Germany, France

Full service

Set-up to recruiting

CPM

Hand dermatitis

260

14

Germany, Switzerland

Full service

Set-up

Medical scientific advisor

Epilepsy

500

12

Germany

Full service

Set-up to end

 

CPM

Lupus erythematosus

260

20

Germany, Austria, Switzerland, USA, Georgia, Russia, Ukraine, Poland

Full service

Set-up

CPM

Cat allergy

88

1

Germany

Full service

Set-up to end

Medical monitor

 

NSCLC

120

50

Canada, Georgia, India, Poland, Romania, Russia, Serbia,

New Zealand, Australia

Full service

Set-up to recruiting

Medical monitor

 

Rheumatoid arthritis

120

30

Canada, Georgia, India, Poland, Romania, Russia, Serbia

 

Full service

Set-up to recruiting

Medical monitor

Acromegaly

140

50

Germany, Czech Republic, Poland, Hungary, Russia, USA

Full service

Set-up to recruiting

CPM / Lead CRA

Pneumonia

610

80

Spain, France, Estonia, Serbia, Georgia, South Africa, Slovakia, Hungary

Full service

Recruiting to end

Medical Advisor

Benign prostate hyperplasia

1500

20

Germany

Set-up

Set-up

Medical Advisor

Prostate Cancer

250

6

Germany, Austria, Switzerland

Set-up

Set-up

Medical Advisor

Invasive fungal infection of liver transplant patients

300 (90 in Germany)

6

Germany, Austria, Switzerland

Set-up to end

Set-up to end

Medical Advisor

Pre-emptive antifungal treatment in patients with peritonitis after surgery

360 (60 in Germany)

5

Germany, Austria, Switzerland

Set-up to end

Set-up to end

Medical advisor

Clostridium difficile infection in high risk immunocompromised patients

650 (150 planned for Germany)

6

Germany

Feasibility

 

Medical reviewer

Transplantation (5 studies)

1500

50

International

Medical review

                             

 

 

 

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