Personal Information
Organization / Workplace
Slough, United Kingdom United Kingdom
Occupation
EU+ Assoc. Medical Director at Biogen
Industry
Medical / Health Care / Pharmaceuticals
About
As EU+ Assoc. Medical Director:
Responsible and signatory for labelling activities in EU+ geographies, and responsible for safety content of responses to product regulatory queries originating from EU+ geographies;
Responsible for the generation of the core and EU RMP for new product/indication filings with support of Epi and Medical Writing; responsible for post-approval maintenance of core RMP and EU RMP for assigned products;
Responsible for overseeing and a signatory of Post-authorization safety studies (PASS) and other assigned studies in EU+ geographies; accountable for input on protocol design, ICF Safety content, study life-cycle activities including participation in interim and e...
Tags
phv
pharmacovigilance
qppv
pv
eu qppv
drug safety
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