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Job Field: Security
Location: Palo Alto, CA
Salary: $Not stated

JOB SUMMARY:

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<tr><td valign="top" width="450"><b>id="tms_job_12-182-210">Director/Sr. Director, Drug Safety and PharmacovigilanceJob Code :12-182-210Division :Jazz PharmaceuticalsLocation :Palo Alto CA US 94304Job Type :Full TimeCareer Level :Manager (Manager/Supervisor of Staff)Education :Master''s DegreeCategory :Biotechnology and PharmaceuticalJob Description :THE POSITIONManages all functions associated with Case Management including the Drug Safety Coordinators, the Drug Safety Associates, and the Drug Safety Physicians using in-depth knowledge of drug safety principles and experience in practical applications of guidelines and current global regulations governing expedited and periodic safety reporting, and provides guidance to the Drug Safety and Pharmacovigilance group to identify and pursue global and long-term goals for the department. Takes lead for designated project(s) related to generating sound medical and high quality documentation on Jazz Pharmaceuticals adverse drug experience and risk management activities while complying with regulations worldwide, provides training on the principles and practices of drug safety to Company personnel or to external groups. Participates in strategic planning, workflow development, SOP updates, audits, data analysis and team meetings pertaining to their projects. Reviews the work of safety associates for quality and completeness and to establish any further action required.RESPONSIBILITIESOversight and review of safety practices involving all phases of clinical research (activities include, but are not limited to):* Processes adverse event information received by the Drug Safety and Pharmacovigilance department* Manage the group of Case Management and ensures process consistency across Jazz Pharmaceutical products and sites. Initiate regular meetings, provides individual goals, monitors individual and team results* Ensure compliance with SOPs and US/EU/International regulations for the reporting of adverse events to regulatory agencies* Actively participate in the development, implementation, maintenance and delivery of Drug Safety department training programs and initiatives * Collaborate with senior staff in Drug Safety and Pharmacovigilance department to achieve the objectives of the Department* Ensure the Drug Safety and Pharmacovigilance staff is updated on the most current domestic and international regulations relevant to a Drug Safety organization (new ICH steps, new FDA or international guidelines, etc&hellip;)* Closely monitor the case processing from receipt to case closure in the Drug Safety database including query generation, narrative writing, and medical review* Ensure consistency of MedDRA coding and development / revision of MedDRA Coding Conventions, ensuring consistent data categorization* Defines and applies a high standard of case quality review to ensure sound medical safety data documentation* Review PADERs, PSURs, and clinical documents including study protocols, case report forms, Investigator Brochures and IND Annual Reports* Updates drug safety forms and templates in harmonization with relevant clinical operation forms and templates (i.e. MedCOMM form, SAE data collection form and CRF)* Collaborate with other departments to ensure appropriate collection and handling of safety data* Prepare for and attend the Pharmacovigilance CommitteeJob Requirements :* MD and minimum of five years of experience in Drug Safety and Pharmacovigilance in a management position* RN or RPh and minimum of eight years of experience in Drug Safety and Pharmacovigilance in a management position* MS/MA degree in related discipline and ten years of experience in Drug Safety and Pharmacovigilance in a management position ; or,* Equivalent combination of education and experience.* Has successful previous management experience* Develops technical and/or business solutions to complex problems* Identifies and implements methods, techniques, procedures and evaluation criteria to achieve results* Guides the successful completion of

KEY REQUIREMENTS:

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