Experience

DADA Consultancy B.V.

• Netherlands
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Director Pharmacovigilance / Managing partner

  • Jan 2014 - Present

  As Managing partner at DADA Consultancy B.V., I am part of the Management Team to run the day-to-day business as well as define the strategic goals of the company. As the Director Pharmacovigilance, I manage a slowly expanding team of pharmacovigilance specialists in conducting drug safety activities on behalf of pharmaceutical companies situated globally. Our team can function as the outsourced pharmacovigilance department of a company lacking the necessary resources and/or experience, or assist in taking over smaller tasks such as report writing during capacity problems or function as local contact point for adverse reaction reports, medical enquiries or product complaints for several EU countries, all depending on our clients needs. I manage this team, but in addition provide clients with tailor-made offers for support, function as (local/EU/deputy) QPPV when requested, provide pharmacovigilance strategy advice. Show less

• Senior Pharmacovigilance Consultant

  • Jun 2010 - Dec 2013

  Manage the pharmacovigilance (PV) system and act as QPPV for multiple international clients, advise on PV issues (PV system, risk management, regulatory compliance), as of 01 January 2013 as a Senior Consultant, and manage the DADA Pharmacovigilance department in performing various PV tasks on demand such as writing PSURs, RMPs, and other aggregate reports, and conducting case processing, literature screening and signal detection.



DNC Resources B.V.

• Pharmacovigilance Specialist

  • Apr 2010 - May 2010

  From April to May 2010 I have performed my tasks in Oss as an employee of DNC Science. From April to May 2010 I have performed my tasks in Oss as an employee of DNC Science.



Merck

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Safety Surveillance Coordinator

  • Apr 2008 - May 2010

  Evaluate and report safety aspects of investigational and marketed Organon products in Anaesthesiology and Urology, producing periodic safety update reports and anual safety reports, triage patient reports, conduct surveillance and signal detection and prepare risk management plans, manage case quality. Evaluate and report safety aspects of investigational and marketed Organon products in Anaesthesiology and Urology, producing periodic safety update reports and anual safety reports, triage patient reports, conduct surveillance and signal detection and prepare risk management plans, manage case quality.



INC Research

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Pharmacovigilance Specialist

  • Apr 2008 - Mar 2010

  Outsourced to Organon as Safety Surveillance Coordinator to perform pharmacovigilance activities in the Drug Safety Surveillance Department. Outsourced to Organon as Safety Surveillance Coordinator to perform pharmacovigilance activities in the Drug Safety Surveillance Department.



Synthon

• Netherlands
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Pharmacovigilance Officer

  • Jan 2006 - Mar 2008

  Manage safety data exchange agreements with marketing partners, database management of patient reports, give training on and perform data entry of patient reports, quality control and reporting, write periodic reports on the risk-benefit balance of pharmaceutical products by evaluating literature, case reports and all other relevant sources. Monitor the department for quality and compliance. Manage standard operating procedures, serve as back up for the head of the department (DSO). Manage safety data exchange agreements with marketing partners, database management of patient reports, give training on and perform data entry of patient reports, quality control and reporting, write periodic reports on the risk-benefit balance of pharmaceutical products by evaluating literature, case reports and all other relevant sources. Monitor the department for quality and compliance. Manage standard operating procedures, serve as back up for the head of the department (DSO).



Radboud University

• Netherlands
• Research Services
• 700 & Above Employee

• Researcher

  • Jan 2001 - Jul 2005

  Junior Onderzoeker/PhD student, hormonal regulation of skin colour change and stress responses in an animal model (the fish). Present findings at (inter)national meetings and congresses and publish scientific literature articles in peer reviewed journals. For my thesis, visit: http://webdoc.ubn.ru.nl/mono/s/salm_a_van_der/alphinfi.pdf Junior Onderzoeker/PhD student, hormonal regulation of skin colour change and stress responses in an animal model (the fish). Present findings at (inter)national meetings and congresses and publish scientific literature articles in peer reviewed journals. For my thesis, visit: http://webdoc.ubn.ru.nl/mono/s/salm_a_van_der/alphinfi.pdf



Radboud University Nijmegen

• PhD student

  • 2001 - 2005

  Hormonal regulation of skin colour change and stress responses in an animal model (the fish). Supervise biology students during their MSc work experience as part of my research. Hormonal regulation of skin colour change and stress responses in an animal model (the fish). Supervise biology students during their MSc work experience as part of my research.