Dr. Evelyn O'Brien
Selbstständig, International Pharmacovigilance Specialist (Consultant), Astellas Pharma Europe B.V.
Dublin, Irland
Werdegang
Berufserfahrung von Evelyn O'Brien
Bis heute 10 Jahre, seit Juli 2014
International Pharmacovigilance Specialist (Consultant)
Astellas Pharma Europe B.V.
Pharmacovigilance systems and documentation; scientific and medical writing; review & editing of scientific publications and regulatory authority documentation. Study reports; Legislation review and implementatio. Creation and maintenance of global templates & and SOPs. Organisation of scientific meetings and conferences. Currently on assignment to Astellas Pharma Europe as Global Business Partner Manager (PV) negotiating pharmacovigilance contracts between Astellas and global business partners.
8 Monate, Sep. 2013 - Apr. 2014
Manager Drug Safety
Novartis (Ireland)
Establishment, implementation and adaptation of a local pharmacovigilance system; Survey of relevant legislation; Interdepartmental communication; Quality management of pharmacovigilance system; Audit preparation; Writing and maintaining of SOPs; Local contact for competent authorities; Registration and follow up of adverse drug reactions for signal detection, PSUR & DSUR purposes; Reporting compliance; Pharmacovigilance training of all employees at relevant level; CAPA plans
2 Jahre und 6 Monate, Okt. 2008 - März 2011
Group leader
Smithers Viscient (formerly Springborn Smithers Laboratories)
Environmental (aquatic & terrestrial) testing carried out under GLP and according to international guidelines (OECD, OPPTS, ISO, JMAFF); Standard and tailored study design; Data analysis, reporting and presentation for registration dossiers for REACH and EMEA submissions; Budget control and quotation preparation; Team leading and human resource management; Business development; Purchasing incl. preferred provider negotiations; Client and regulatory authority communication.
Ausbildung von Evelyn O'Brien
4 Jahre und 1 Monat, Okt. 1992 - Okt. 1996
Pharmacology
University College DUblin
Toxicology Cell biology
Sprachen
Deutsch
Fließend
Englisch
Muttersprache
Französisch
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