Medical Review, Safety
Aktualisiert am 18.10.2023
Profil
Freiberufler / Selbstständiger
Remote-Arbeit
Verfügbar ab: 18.10.2023
Verfügbar zu: 25%
davon vor Ort: 100%
Medical Review
Safety
German
Mother Tongue
English
Business Fluent
French
Good Knowledge
Spanish
Good Knowledge

Einsatzorte

Einsatzorte

Deutschland, Schweiz, Österreich
möglich

Projekte

Projekte

4 Monate
2022-04 - 2022-07

Pharmacovigilance Consulting

Pharmacovigilance Consultant
Pharmacovigilance Consultant


Fresenius-Kabi, Switzerland
8 Monate
2021-04 - 2021-11

various Projects

Medical Reviewer/ Head of Pharmacovigilance
Medical Reviewer/ Head of Pharmacovigilance
  • 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

Immunic, Gräfelfing
3 Jahre 3 Monate
2018-08 - 2021-10

Medical review of study data in ophthamology

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

Bayer, Berlin
9 Monate
2020-04 - 2020-12

Medical review of studies in diffuse large b-cell lymphoma

Medical Reviewer
Medical Reviewer



Morphosys, Planegg
6 Monate
2019-07 - 2019-12

Medical Review for a Phase II study in transplantation

Medical Reviewer (part-time freelance position)
Medical Reviewer (part-time freelance position)


Novartis, Basel
8 Monate
2019-01 - 2019-08

Signal detection and Safety report writing for various drugs

Medical Safety Expert (part-time freelance position)
Medical Safety Expert (part-time freelance position)

 

Abbott,Hannover
6 Jahre 6 Monate
2012-07 - 2018-12

Medical review of international studies in transplantation and juvenile arthritis

Medical Reviewer (fulltime freelance position)
Medical Reviewer (fulltime freelance position)

  

Novartis, Basel
3 Jahre
2009-06 - 2012-05

Management of international studies

Medical Advisor (in-house fulltime freelance position)
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 liver transplantation, Phase III
  • Pre-emptive invasive fungal infection therapy in patients with peritonitis after abdominal surgery, Phase II
  • Clostridium difficile infection treatment in high risk immunocompromised patients, Phase III

Astellas Pharma GmbH, München
2 Jahre 9 Monate
2006-10 - 2009-06

various Projects

Project Manager/ Medical Monitor
Project Manager/ Medical Monitor

2006-10 ? 2008-09

Role: Project Manager 


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


2008-10 - 2009-06

Role: Medical Monitor


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

  • NSCLC, Phase II
  • Rheumatoid arthritis, Phase II
  • Acromegaly, Phase III

Pharm-Olam International, München
2 Jahre 3 Monate
2004-07 - 2006-09

Responsible for 12 investigator initiated studies

Medical Scientific Advisor
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

UCB GmbH, Kerpen
1 Jahr 5 Monate
2003-02 - 2004-06

Project Management

Project Manager/CRA
Project Manager/CRA
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

MDS Pharma Services, Langenfeld
1 Monat
2002-04 - 2002-04

Protocol development for a phase I study

Medical Advisor
Medical Advisor

  

Viscum AG, Bergisch Gladbach
2 Jahre 8 Monate
1999-08 - 2002-03

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

Safety Officer
Safety Officer


Omnicare Clinical Research, Cologne
5 Jahre 9 Monate
1996-07 - 2002-03

various Projects


Omnicare Clinical Research, Cologne
2 Jahre 7 Monate
1997-01 - 1999-07

Project Management of national and international studies phase III

Project Manager
Project Manager

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

Omnicare Clinical Research, Cologne
6 Monate
1996-07 - 1996-12

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

Medical Writer/CRA
Medical Writer/CRA

Medical Writer

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


Omnicare Clinical Research, Cologne

Aus- und Weiterbildung

Aus- und Weiterbildung

Dissertation

1992 - 1998

University of Cologne

title of Dissertation: on Request


Studies

1985 -1992

University of Cologne

Human medicine (MD)

Graduation: License to practice medicine


1974 - 1983

Secondary school in Leverkusen

Graduation: University-entrance diploma


1970 - 1974

Primary school in Leverkusen


Civilian Service

1984-04 ? 1985-02

Mobile social service, ?Arbeiterwohlfahrt?, Cologne


1983-11 ? 1984-03

Home for the aged in Leverkusen


Kompetenzen

Kompetenzen

Top-Skills

Medical Review Safety

Produkte / Standards / Erfahrungen / Methoden

Therapeutic Experience
  • Cardiovascular Gastroenterology
  • Gynaecology Immunology
  • Infectious diseases Musculoskeletal
  • Nephrology Neurology
  • Oncology Psychiatry


Resident 

1996-01 ? 1996-06                             

Rheinische Landes ? und Hochschulklinik Düsseldorf (Psychiatry)


1994-10 ? 1995-09        

Private practice Dr. Storch, Düren (Nuclear medicine

Einsatzorte

Einsatzorte

Deutschland, Schweiz, Österreich
möglich

Projekte

Projekte

4 Monate
2022-04 - 2022-07

Pharmacovigilance Consulting

Pharmacovigilance Consultant
Pharmacovigilance Consultant


Fresenius-Kabi, Switzerland
8 Monate
2021-04 - 2021-11

various Projects

Medical Reviewer/ Head of Pharmacovigilance
Medical Reviewer/ Head of Pharmacovigilance
  • 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

Immunic, Gräfelfing
3 Jahre 3 Monate
2018-08 - 2021-10

Medical review of study data in ophthamology

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

Bayer, Berlin
9 Monate
2020-04 - 2020-12

Medical review of studies in diffuse large b-cell lymphoma

Medical Reviewer
Medical Reviewer



Morphosys, Planegg
6 Monate
2019-07 - 2019-12

Medical Review for a Phase II study in transplantation

Medical Reviewer (part-time freelance position)
Medical Reviewer (part-time freelance position)


Novartis, Basel
8 Monate
2019-01 - 2019-08

Signal detection and Safety report writing for various drugs

Medical Safety Expert (part-time freelance position)
Medical Safety Expert (part-time freelance position)

 

Abbott,Hannover
6 Jahre 6 Monate
2012-07 - 2018-12

Medical review of international studies in transplantation and juvenile arthritis

Medical Reviewer (fulltime freelance position)
Medical Reviewer (fulltime freelance position)

  

Novartis, Basel
3 Jahre
2009-06 - 2012-05

Management of international studies

Medical Advisor (in-house fulltime freelance position)
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 liver transplantation, Phase III
  • Pre-emptive invasive fungal infection therapy in patients with peritonitis after abdominal surgery, Phase II
  • Clostridium difficile infection treatment in high risk immunocompromised patients, Phase III

Astellas Pharma GmbH, München
2 Jahre 9 Monate
2006-10 - 2009-06

various Projects

Project Manager/ Medical Monitor
Project Manager/ Medical Monitor

2006-10 ? 2008-09

Role: Project Manager 


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


2008-10 - 2009-06

Role: Medical Monitor


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

  • NSCLC, Phase II
  • Rheumatoid arthritis, Phase II
  • Acromegaly, Phase III

Pharm-Olam International, München
2 Jahre 3 Monate
2004-07 - 2006-09

Responsible for 12 investigator initiated studies

Medical Scientific Advisor
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

UCB GmbH, Kerpen
1 Jahr 5 Monate
2003-02 - 2004-06

Project Management

Project Manager/CRA
Project Manager/CRA
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

MDS Pharma Services, Langenfeld
1 Monat
2002-04 - 2002-04

Protocol development for a phase I study

Medical Advisor
Medical Advisor

  

Viscum AG, Bergisch Gladbach
2 Jahre 8 Monate
1999-08 - 2002-03

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

Safety Officer
Safety Officer


Omnicare Clinical Research, Cologne
5 Jahre 9 Monate
1996-07 - 2002-03

various Projects


Omnicare Clinical Research, Cologne
2 Jahre 7 Monate
1997-01 - 1999-07

Project Management of national and international studies phase III

Project Manager
Project Manager

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

Omnicare Clinical Research, Cologne
6 Monate
1996-07 - 1996-12

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

Medical Writer/CRA
Medical Writer/CRA

Medical Writer

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


Omnicare Clinical Research, Cologne

Aus- und Weiterbildung

Aus- und Weiterbildung

Dissertation

1992 - 1998

University of Cologne

title of Dissertation: on Request


Studies

1985 -1992

University of Cologne

Human medicine (MD)

Graduation: License to practice medicine


1974 - 1983

Secondary school in Leverkusen

Graduation: University-entrance diploma


1970 - 1974

Primary school in Leverkusen


Civilian Service

1984-04 ? 1985-02

Mobile social service, ?Arbeiterwohlfahrt?, Cologne


1983-11 ? 1984-03

Home for the aged in Leverkusen


Kompetenzen

Kompetenzen

Top-Skills

Medical Review Safety

Produkte / Standards / Erfahrungen / Methoden

Therapeutic Experience
  • Cardiovascular Gastroenterology
  • Gynaecology Immunology
  • Infectious diseases Musculoskeletal
  • Nephrology Neurology
  • Oncology Psychiatry


Resident 

1996-01 ? 1996-06                             

Rheinische Landes ? und Hochschulklinik Düsseldorf (Psychiatry)


1994-10 ? 1995-09        

Private practice Dr. Storch, Düren (Nuclear medicine

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