Michael Bloh

Seasoned professional in drug safety, pharmacovigilance and risk management at Open to new opportunities in drug safety, pharmacovigilance and risk management, Associate Director | Consultant | Pharmacovigilance at Full time, contract and consultant opportunities, Founder || Assistant Director | Manager | Pharmacovigilance at Visionaries in Pharmacovigilance

Greater Philadelphia Area

Pharmaceuticals

Open to new opportunities in drug safety, pharmacovigilance and risk management - Newtown Square, PA 19073 USA since Jan 2012
Seasoned professional in drug safety, pharmacovigilance and risk management
Full time, contract and consultant opportunities since Jan 2012
Associate Director | Consultant | Pharmacovigilance
Visionaries in Pharmacovigilance - Greater Philadelphia Area since 2012
Founder || Assistant Director | Manager | Pharmacovigilance
Schering-Plough Research Institute 2008 - 2010
Signal Detection Specialist

Drexel University - College of Business and Administration
MBA, Management Philadelphia College of Pharmacy and Science
BSc, Pharmacy

Drug Safety Pharmacovigilance Risk Management Signal detection and evaluation Pharmacovigilance plans Risk Management Plans Risk MaPPs Clinical Research Clinical Trials Medical Writing, Review, Editing Periodic Risk Benefit Evaluation Reports (PBRERs) Periodic Safety Update Reports (PSURs) Clinical Study Reports (CSRs) Quarterly Study Reports (QSRs) Annual Study Reports (ASRs) US PADER reports Published Author Regulatory Affairs Global Regulatory Compliance FDA, EU. EMEA, Eudravigilance SOP evaluation and creation FDA Inspections EU, MHRA Inspections Inspection preparedness training AE database selection, validation and project managment Data review, analysis and evaluation Adhoc AE requests from Healh Authorities PV training and development Employee selection, training and evaluation Review and evaluation of medical literature Persuasive Presentations Budgeting and Resource Planning

DIA Outstanding Contributor to Clinical Safety and Pharmacovigilance Special Interest Community Aventis Pasteur Significant Contributor to Pharmacovigilance Systems Implementation