Drug Safety - Pharmakovigilanz
Aktualisiert am 27.05.2020
Profil
Freiberufler / Selbstständiger
Verfügbar ab: 06.06.2020
Verfügbar zu: 100%
davon vor Ort: 40%
Good Pharmacovigilance Practice
Drug Safety
English
business fluent (level C2)
French
basics (on course)
German
mother tongue
Italian
fluent (level C1)

Einsatzorte

Einsatzorte

Deutschland, Österreich, Schweiz
nicht möglich

Projekte

Projekte

7 Jahre 9 Monate
2016-07 - heute

Pharmacovigilance, Set-up and Maintenance

CEO and Managing Director
CEO and Managing Director
  • Pharmacovigilance, Set-up and Maintenance of Drug Safety Processes, Compliance, Key Performance Indicators, Quality Control, Late Case, CAPA & SOP Management, PV Training, interaction with regulatory affairs (CCSI and SmPC update)
  • Risk Assessment ICHQ3D – elemental impurities
[on request]
6 Jahre 4 Monate
2011-03 - 2017-06

Scientific Services: Workshop Organization, Scientific Publications

CEO and Managing Director
CEO and Managing Director
[on request]
2 Jahre 3 Monate
2014-07 - 2016-09

various tasks

Compliance & Training Specialist
Compliance & Training Specialist
  • Drug Safety, Pharmacovigilance, Compliance, Reconciliation with world-wide partners, PV Training, Late Case Handling, Exception and CAPA Management, Set up and monthly evaluation of Key Performance Indicators:Timely Processing of ICSRs, Signal Detection, CCSI Update (SmPC check), PSUR Submission
Mallinckrodt, Germany
5 Jahre 3 Monate
2011-01 - 2016-03

Meeting Organization, Scientific Publications, Workshops, Reports, Project Management

Scientific Officer
Scientific Officer
CAAT-Europe
University of Konstanz
2 Jahre 7 Monate
2011-12 - 2014-06

Drug Safety

Scientific Freelancer
Scientific Freelancer
  • Drug Safety, Pharmacovigilance, Medical Translation, Medical Communication, Case Handling and Query Management
syneed medidata GmbH
Konstanz
1 Jahr
2010-01 - 2010-12

Alternatives to Animal Experiments

Scientific Consultant
Scientific Consultant
3 Jahre
2006-12 - 2009-11

Development of ?in vitro? methods

Scientific Officer
Scientific Officer
  • Development of ‘in vitro’ methods used for toxicological substance testing of drugs based on human embryonic stem cells and the ethical background embryonic stem cells
  • Participation and responsibility in various European projects, including meetings and workshops preparation and participation, reporting, advisory role
European Commission (EC), Joint Research Centre (JRC), Institute for Health and Consumer Protection (IHCP), In-vitro Methods, Reproductive Toxicity
3 Jahre
2003-12 - 2006-11

various tasks

Scientific Officer
Scientific Officer
  • Development of ”in vitro” methods in cooperation with the physical-chemical unit (acquirement of inter-disciplinary knowledge)
  • Advisory role to apply physical-chemical methods and nanotechnology to biological and medical applications
European Commission (EC), JRC, IHCP, ECVAM (European Centre for the Validation of Alternative Methods), in cooperation with the group ?Nanobiotechnology?

Aus- und Weiterbildung

Aus- und Weiterbildung

10/2006

Dissertation

10/2002 ? 11/2003:

PhD student at the University of Konstanz at the Chair of Biochemical Pharmacology


10/1995 ? 09/2002:

Biology studies at the University of Konstanz


10/1991 ? 09/1992:

Law studies at the University of Konstanz


06/1991:

Abitur/graduation at the Tagesheimgymnasium Kerpen, Germany

Special courses

  • Drug Safety Manager / Signal Detection
  • Risk and Hazard Assessment
  • Principles of Good Laboratory Practices (GLP)
  • Communication Skills and Conflict Management
  • Training of Public Speaking
  • Basics of Project Management and Microsoft Project
  • Chairing and Conducting Meetings

Kompetenzen

Kompetenzen

Top-Skills

Good Pharmacovigilance Practice Drug Safety

Produkte / Standards / Erfahrungen / Methoden

Computer skills

  • Microsoft Office (Word, Excel, Power Point)
  • Adobe Acrobat, Photoshop
  • Softmax Pro and GraphPad Prism (data and statistical analysis)
  • Endnote (literature database)
  • ARGUS, Empirica Topics, PVQ, Insight databases

Technical skills

  • Pharmacovigilance: drug safety, case processing, query management, reconciliation with world-wide partners, medical coding, medical translation, late case processing, exception and CAPA management, all in regard to clinical trials, post-marketing studies and spontaneous reports. ARGUS database, Training of National Responsible persons
  • Project initiation, planning and the implementation in cooperation-based networks as focal point in between biology, chemistry and physics in the frame of European projects
  • Organization of workshops und meetings including chairmanship, minutes and final report
  • Inter-disciplinary knowledge in the drug developmental process, pre-clinical toxicology of drugs, REACH, Cosmetics and the related guidelines, biology, immunology, plasma physics, surface chemistry plus characterization and human embryonic stem cells
  • Expertise in the validation and development of toxicity testing methods including the requirements and guidelines (e.g. ICH, OECD, REACH)
  • Various cell lines, maintenance and the set up of experiments used for substance testing in toxicology

miscellaneous

10/1992 ? 09/1995:

Maternity leave

Einsatzorte

Einsatzorte

Deutschland, Österreich, Schweiz
nicht möglich

Projekte

Projekte

7 Jahre 9 Monate
2016-07 - heute

Pharmacovigilance, Set-up and Maintenance

CEO and Managing Director
CEO and Managing Director
  • Pharmacovigilance, Set-up and Maintenance of Drug Safety Processes, Compliance, Key Performance Indicators, Quality Control, Late Case, CAPA & SOP Management, PV Training, interaction with regulatory affairs (CCSI and SmPC update)
  • Risk Assessment ICHQ3D – elemental impurities
[on request]
6 Jahre 4 Monate
2011-03 - 2017-06

Scientific Services: Workshop Organization, Scientific Publications

CEO and Managing Director
CEO and Managing Director
[on request]
2 Jahre 3 Monate
2014-07 - 2016-09

various tasks

Compliance & Training Specialist
Compliance & Training Specialist
  • Drug Safety, Pharmacovigilance, Compliance, Reconciliation with world-wide partners, PV Training, Late Case Handling, Exception and CAPA Management, Set up and monthly evaluation of Key Performance Indicators:Timely Processing of ICSRs, Signal Detection, CCSI Update (SmPC check), PSUR Submission
Mallinckrodt, Germany
5 Jahre 3 Monate
2011-01 - 2016-03

Meeting Organization, Scientific Publications, Workshops, Reports, Project Management

Scientific Officer
Scientific Officer
CAAT-Europe
University of Konstanz
2 Jahre 7 Monate
2011-12 - 2014-06

Drug Safety

Scientific Freelancer
Scientific Freelancer
  • Drug Safety, Pharmacovigilance, Medical Translation, Medical Communication, Case Handling and Query Management
syneed medidata GmbH
Konstanz
1 Jahr
2010-01 - 2010-12

Alternatives to Animal Experiments

Scientific Consultant
Scientific Consultant
3 Jahre
2006-12 - 2009-11

Development of ?in vitro? methods

Scientific Officer
Scientific Officer
  • Development of ‘in vitro’ methods used for toxicological substance testing of drugs based on human embryonic stem cells and the ethical background embryonic stem cells
  • Participation and responsibility in various European projects, including meetings and workshops preparation and participation, reporting, advisory role
European Commission (EC), Joint Research Centre (JRC), Institute for Health and Consumer Protection (IHCP), In-vitro Methods, Reproductive Toxicity
3 Jahre
2003-12 - 2006-11

various tasks

Scientific Officer
Scientific Officer
  • Development of ”in vitro” methods in cooperation with the physical-chemical unit (acquirement of inter-disciplinary knowledge)
  • Advisory role to apply physical-chemical methods and nanotechnology to biological and medical applications
European Commission (EC), JRC, IHCP, ECVAM (European Centre for the Validation of Alternative Methods), in cooperation with the group ?Nanobiotechnology?

Aus- und Weiterbildung

Aus- und Weiterbildung

10/2006

Dissertation

10/2002 ? 11/2003:

PhD student at the University of Konstanz at the Chair of Biochemical Pharmacology


10/1995 ? 09/2002:

Biology studies at the University of Konstanz


10/1991 ? 09/1992:

Law studies at the University of Konstanz


06/1991:

Abitur/graduation at the Tagesheimgymnasium Kerpen, Germany

Special courses

  • Drug Safety Manager / Signal Detection
  • Risk and Hazard Assessment
  • Principles of Good Laboratory Practices (GLP)
  • Communication Skills and Conflict Management
  • Training of Public Speaking
  • Basics of Project Management and Microsoft Project
  • Chairing and Conducting Meetings

Kompetenzen

Kompetenzen

Top-Skills

Good Pharmacovigilance Practice Drug Safety

Produkte / Standards / Erfahrungen / Methoden

Computer skills

  • Microsoft Office (Word, Excel, Power Point)
  • Adobe Acrobat, Photoshop
  • Softmax Pro and GraphPad Prism (data and statistical analysis)
  • Endnote (literature database)
  • ARGUS, Empirica Topics, PVQ, Insight databases

Technical skills

  • Pharmacovigilance: drug safety, case processing, query management, reconciliation with world-wide partners, medical coding, medical translation, late case processing, exception and CAPA management, all in regard to clinical trials, post-marketing studies and spontaneous reports. ARGUS database, Training of National Responsible persons
  • Project initiation, planning and the implementation in cooperation-based networks as focal point in between biology, chemistry and physics in the frame of European projects
  • Organization of workshops und meetings including chairmanship, minutes and final report
  • Inter-disciplinary knowledge in the drug developmental process, pre-clinical toxicology of drugs, REACH, Cosmetics and the related guidelines, biology, immunology, plasma physics, surface chemistry plus characterization and human embryonic stem cells
  • Expertise in the validation and development of toxicity testing methods including the requirements and guidelines (e.g. ICH, OECD, REACH)
  • Various cell lines, maintenance and the set up of experiments used for substance testing in toxicology

miscellaneous

10/1992 ? 09/1995:

Maternity leave

Vertrauen Sie auf GULP

Im Bereich Freelancing
Im Bereich Arbeitnehmerüberlassung / Personalvermittlung

Fragen?

Rufen Sie uns an +49 89 500316-300 oder schreiben Sie uns:

Das GULP Freelancer-Portal

Direktester geht's nicht! Ganz einfach Freelancer finden und direkt Kontakt aufnehmen.