Ea Dige
Drug Safety Manager at PharmAdvice ApS- Claim this Profile
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English Full professional proficiency
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Danish Native or bilingual proficiency
Topline Score
Bio
LinkedIn User
One of the best hires I ever made in my 20+ years in the business.
© Kim Simonsen ©
I have come to know Ea as a very competent professional in the field of Pharmacovigilance. She has guided the company through the build up of the pharmacovigilance functions both centraly and within affiliated companies in compliance with the increasing legal and public requirements. She has also been instrumental in the set up of pharmacovigilance agreements with external partners concerning our products. I am very comfortable with her in the role as our Qualified Person Pharmacovigilance. She is also actively contributing value as a participant in the management team of Group Clinical Development.
LinkedIn User
One of the best hires I ever made in my 20+ years in the business.
© Kim Simonsen ©
I have come to know Ea as a very competent professional in the field of Pharmacovigilance. She has guided the company through the build up of the pharmacovigilance functions both centraly and within affiliated companies in compliance with the increasing legal and public requirements. She has also been instrumental in the set up of pharmacovigilance agreements with external partners concerning our products. I am very comfortable with her in the role as our Qualified Person Pharmacovigilance. She is also actively contributing value as a participant in the management team of Group Clinical Development.
LinkedIn User
One of the best hires I ever made in my 20+ years in the business.
© Kim Simonsen ©
I have come to know Ea as a very competent professional in the field of Pharmacovigilance. She has guided the company through the build up of the pharmacovigilance functions both centraly and within affiliated companies in compliance with the increasing legal and public requirements. She has also been instrumental in the set up of pharmacovigilance agreements with external partners concerning our products. I am very comfortable with her in the role as our Qualified Person Pharmacovigilance. She is also actively contributing value as a participant in the management team of Group Clinical Development.
LinkedIn User
One of the best hires I ever made in my 20+ years in the business.
© Kim Simonsen ©
I have come to know Ea as a very competent professional in the field of Pharmacovigilance. She has guided the company through the build up of the pharmacovigilance functions both centraly and within affiliated companies in compliance with the increasing legal and public requirements. She has also been instrumental in the set up of pharmacovigilance agreements with external partners concerning our products. I am very comfortable with her in the role as our Qualified Person Pharmacovigilance. She is also actively contributing value as a participant in the management team of Group Clinical Development.
Experience
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PharmAdvice ApS
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Denmark
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Drug Safety Manager
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Jan 2015 - Present
Responsible for pharmacovigilance assignments for clients including in-house pharmacovigilance system. Handling of ISCRs. Medical review of documents for regulatory submission. Responsible for pharmacovigilance assignments for clients including in-house pharmacovigilance system. Handling of ISCRs. Medical review of documents for regulatory submission.
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Lægemiddelstyrelsen (Danish Medicines Agency)
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Denmark
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Government Administration
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400 - 500 Employee
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Senior Medical Officer
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Jan 2014 - Dec 2014
Assessment of the clinical safety and efficacy of medicines Assessment of the clinical safety and efficacy of medicines
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ALK
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Denmark
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Pharmaceutical Manufacturing
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700 & Above Employee
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Director of Pharmacovigilance
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Oct 2002 - Dec 2013
Qualified Person for Pharmacovigilance. Part of the management team for the Pharmacovigilance department, Implementation of 2012 PV legislation including set-up of first version of Pharmacovigilance system master file (PSMF) Chair of the Internal safety committee and the Core labelling committee. Strong supporter of crossfunctional collaboration with Regulatory function and Medical Information. Training and supervision of Drug Safety Advisers on medical safety and signal management. Had 8 direct reports from 2002 to 2008 Show less
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Sanofi
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France
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Pharmaceutical Manufacturing
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700 & Above Employee
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Director - Pharmacovigilance
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May 2000 - Sep 2002
Project safety responsible for clinical trial in cardiac surgery; Review and input to protocols, besides have the primary focus on the safety aspects of the programmes Primary Safety Responsible for a number of launched products in CNS therapeutic area. Project safety responsible for clinical trial in cardiac surgery; Review and input to protocols, besides have the primary focus on the safety aspects of the programmes Primary Safety Responsible for a number of launched products in CNS therapeutic area.
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Johnson & Johnson
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United States
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Hospitals and Health Care
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700 & Above Employee
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Director
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Jan 1998 - Mar 2000
Worked as Medical Director / Safety responsible for several large projects Project safety responsible for clinical trial for CNS product with development programmes in Analgesics, Epilepsy, Psychiatry and Metabolism Safety responsible for a portefolio of launched products with responsibilities for aggregate reports and signal surveillance Worked as Medical Director / Safety responsible for several large projects Project safety responsible for clinical trial for CNS product with development programmes in Analgesics, Epilepsy, Psychiatry and Metabolism Safety responsible for a portefolio of launched products with responsibilities for aggregate reports and signal surveillance
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Drug Safety adviser
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1991 - 1996
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Education
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1976 - 1984
Københavns Universitet
MD, Medicine
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