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Director Drug Safety (m/f/d)
Eysins (Schweiz)
Aktualität: 22.01.2022


22.01.2022, Fresenius Kabi
Eysins (Schweiz)
Director Drug Safety (m/f/d)
Ongoing safety surveillance and Medical assessment of clinical trials conducted with a Biosimilar Fresenius Kabi compound of all Phases including related tasks Review and comment all human research protocols using biosimilar compounds of the BU including those from countries regions Ongoing safety surveillance for all post approval non clinical elements Compile safety information for aggregate safety reports and other safety related reports pre and postapproval Review and update existing standard operating procedures (SOPs) and own new SOPs for safety department as indicated Oversee work performed by a safety Contract Research Organization (CRO) SMP, PUR, PSMF, RMP input, Quarterly Metrics Review Audits and Inspection Safety Lead, CAPA tracking and implementation (CAPA management is with each party depending on the deviation) Support of market units for service provider vendor management in postapproval period Product knowledge and training Provision of 24-hour availability for QPPV medical support Ensure compliance in case processing according to internal timelines and timely reporting internally and externally Signal detection, Medical review of and input to the safety-relevant sections of Case Report Forms, Informed Consent Forms and Study Protocols Evaluation of relevant literature Accountable and responsible for Coordination, maintenance, and oversight of Safety projects supported by external service providers Close cooperation with global safety Management responsibilities for the Safety and PV team under assignments
Fluency in English; German and/or French would be beneficial Phd, MD with a minimum of 7 y in safety in industry or comparable organization Min. 2 years experience in managing people Strong project management skill set Demonstrated ability to work well with other accomplished professionals within and across functions/teams Willing collaborator with strong written and oral communication skills Ability to multi-task and shift priorities rapidly to meet tight deadlines Self-motivated and keen to improve processes and overcome inefficiencies Hands on attitude Ability to work in an international and global set up Understanding of drug development and postapproval safety requirements Proficient in Microsoft Office suite and applications



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