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Job Field: Security
Location: Santa Clara, CA
Salary: $Not stated

JOB SUMMARY:

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<tr><td valign="top" width="450"><b>Regulatory and Quality AssuranceSafety Operations, Director/Senior Director(Job Code 3540.100812.GB)The Director of Drug Safety Operations will lead the XenoPort Integrated Product Safety Department in the development, implementation and maintenance of systems for all Drug Safety activities, encompassing processes, procedures, compliance and metrics of global safety database activities, drug safety reporting and quality systems covering all Drug Safety activities, including processes, procedures, compliance and metrics.Responsibilities include* participation with senior management to establish strategic safety plans and objectives;* participating in the selection, implementation and maintenance of global safety database and signal detection systems;* acting as Integrated Product Safety lead for a full range of pharmacovigilance activities including operational activities and cross-functional activities with other departments (e.g., Biometrics, Clinical Operations, Clinical Sciences, Regulatory, Sales and Marketing),* developing and implementing Safety Management Plans, monitor ongoing safety reports, prepare narratives, oversee and manage safety data coding/entry, prepare and review aggregate reports;* oversee preparation, development, implementation and maintenance of standard operating procedures and policies relating to pharmacovigilance (PV) and risk management to ensure compliance with ICH guidelines and all regulatory requirements;* developing and conducting training as necessary; and* acting as company PV audit/inspection liaison and communicating findings to senior management.RequirementsTypically requires a PharmD or RN with a minimum of 10 years of relevant experience which includes 8 years in drug safety or a BS/Masters degree in life sciences and minimum 12 years of relevant experience which includes 8 years in drug safety. Must have previous experience in effectively managing people. Advanced understanding of good pharmacovigilance practices and current international (principally EU, US and Canada) regulations of drug safety surveillance as well as industry standards and practices. Experience with pharmacovigilance audit process. Knowledge of MedDRA and WHO Drug coding dictionaries. Ability to write SOPs and other working practices and documents within the context of clinical and post-marketing drug safety reporting. Ability to write risk management plans and periodic safety reports. Must have excellent written and oral communication skills, resourcefulness and personal organization skills. Proficiency in Microsoft Excel, PowerPoint and Word.

KEY REQUIREMENTS:

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