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Assoc Director Global Medical Safety Op Phys (Remote)
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- ClinChoice is a clinical CRO dedicated to offering high-quality full development service to biopharmaceutical, medical device, and consumer products clients.
- Our services include clinical operations, project management, biostatistics, data management, regulatory affairs, medical affairs, and pharmacovigilance.
- The Associate Director, Global Medical Safety Operations Physician (GMSOP) has primary responsibility for determining the medical and scientific relevance of adverse event reports within the context of the product's safety profile as well as other products within the same therapeutic area.
- Discuss findings from ICSR review/Analysis of Similar Events (AOSE)/Designated Medical Events (DME) and/or systematic surveillance program and suggest potential safety issues for further evaluation.
- Participate with Medical Safety Officers on preparation of Pharmacovigilance Plans or Risk Management Plans.
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