Sally Chen
Pharmacovigilance Senior Director Pv Head at Genor Biopharma Co., Ltd
Based in Shanghai, China
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Seniority
Director
Department
Science
Location
Shanghai
Industry
Biotechnology Research
Company size
66
Contact information
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s•••••••@genorbio.com
Phone
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Background
About Sally Chen
10 years of experience in individual case processing and risk management in study. Provide safety insights and medical input to clinical study documents (Protocol, ICF, DMP, DVS, MMP, CRF review), Write DSUR, risk control plan/development risk management plan for IND submissionrisk management plan for BLA/NDA submission Proficient in a variety of safety databases including ARISg, RSGT, ARGUS, help Oracle to complete Argus C installation including the Japanese module translate to Chinese module, and complete CFDA SAE report form configuration, ADR report form configuration, PSUR report configuration (cover sheet & event line listing) Set up signal detection and periodic data review processing including safety data review, efficacy data review, investigational product benefit and risk consideration, safety data comparison with the reference drug/the same class drug Good presentation skills, think strategically, and focus on the achievement of business goals
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