Dr. Evelyn O'Brien

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.

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

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.

Toxicology Cell biology