[K-540] - Senior Lead Patient Safety Scientist

(K-540) - Senior Lead Patient Safety ScientistBarcelona, CataloniaImportant Pharmaceutical Company is looking for a Senior Lead Patient Safety Scientist:Essential Requirements:A Bachelor's in sciences/pharmacy/nursing degree or related field with a minimum of 5 years of relevant experience or an advanced degree with a minimum of 3 years of relevant experience.Patient Safety and/or Clinical/Drug Development experience working in or leading safety or scientific activities in at least 3 of the following areas:Clinical drug development (Early and/or Late Phase): develop programmed level safety strategy, including proactive risk identification mitigation planning.Post-Marketing Surveillance (including signal detection evaluation).MAA/BLA submissions (setting strategy; preparation and authoring of the safety-related aspects of the Common Technical Document).Periodic Safety Reports (establish and lead strategy, preparation and authoring).Risk Management Plans (establish and lead strategy, preparation and authoring).Governance board interactions and communication across a range of activities.Good knowledge of PV regulations.Demonstrated ability to handle more than one project simultaneously, prioritizing well and recognizing key issues.Ability to work effectively in an advanced matrix structure.
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