Anastasia-Miruna Dan
Cluj-Napoca, Romanian
Medical Writer
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About Me
Experienced and dedicated pharmacist MPharm, MSc with 5 years of project management experience in Regulatory Affairs, Pharmacovigilance and Patient Safety. Successfully project managed RA deliverables: MAAs DCP for generics, MA variations, MA renewals, PSUR submissions for original medicinal products in various regulatory frameworks EU, LATAM, APAC, GCC, North African countries.
Successfully project managed and authored safety sections of aggregate safety reports PSURs, PSUR updates, PADERs, ACOs, EU Legally Binding Measures and Medical Safety Assessments [Signal Assessments] in various regulatory frameworks: EU, US, non EU European countries, China. Skilled in signal detection literature review, clinical trial and post marketing data review and medical data review. Adept at identifying issues, challenging the status quo and working towards process improvement. Motivated to learn and acquire new skills.
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