La Jolla Pharmaceutical Company is a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies intended to significantly improve outcomes in patients suffering from life-threatening diseases. The Company has several product candidates in development. LJPC-501 is La JollaUas proprietary formulation of angiotensin II for the potential treatment of catecholamine-resistant hypotension.
An experienced physician-scientist with a master training in biostatistics and a Ph.d training in epidemiology. 20 years experience in clinical trials (generating Experimental Evidence, 'EE'), epidemiologic/observational research (Real World Evidence, 'RWE'), and pharmacovigilance. 10+years in biotech and pharmaceutical industry ( various experience in pharmacovigilance and patient safety, clinical development and medical affairs). Skilled in - Signal Management (Signal Detection, Signal Validation and Evaluation, Prioritization; development of signal detection strategy, signal triage), and leading cross-functional safety management team. - Medical review of ICSR (Seriousness, Severity, Causality and Expectedness assessment) - Aggregate safety reports (DSUR, PSUR/PBRER, PADER, Annual Safety Report) - Benefit and Risk Assessment ( Structured B-R assessment, Quantitative and Qualitative B-R assessment) - Risk Management (Develop Risk Management Plan, Risk Evaluation and Mitigation Strategies (REMS) in US and additional Risk Minimisation Measures in EU and other countries) - Risk Communication (CDS, CCSI, local labels, reference safety information in IB, risk language in ICF, Dear Healthcare Professional Letter, Dear Investigator Letter, etc) -Design and execution of clinical trials (phase I-phase IV) and observational studies (using primary data collection or secondary data, including electronic healthcare databases, national registers and biobank in Nordic countries) - Development of clinical/regulatory/filing documents (study protocol, DMC charter, SMP, CSR, ICFs, IB, brief books, CSR, CO, SCE, SCS, RMP,etc) - Critical literature appraisal and synthesis of epidemiological studies and clinical trials, including meta-analysis Knowledgeable in GCPs, ICH guidelines, GVP, FDA/EMA regulations and guidelines in clinical & safety areas.
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