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Senior Director, Safety & Pharmacovigilance (Global Case Management)

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Listing Info

•Direct the operations of the Global Case Management group in US, EMEA and India
•Provide managerial oversight of the Global Safety and Pharmacovigilance Group
•Ensure that inVentiv Health Clinical is in compliance with safety reporting requirements of regulatory authorities
•Ensure that inVentiv Health Clinical meets client expectations and requirements for safety reporting
•Provide regulatory consultation regarding safety reporting for investigational and marketed products
•Prepare documents describing the process for monitoring and reporting serious adverse experiences (e.g., SOPs, user manuals)
•Maintain proficiency in current knowledge of all applicable regulatory guidelines and regulations relating to safety reporting
•Act as project manager for stand-alone Safety and Pharmacovigilance projects
•Provide input to the overall processes, policies and procedures of the review and processing of safety information in the department
•Coordinate with Medical Affairs, Clinical Research, Data Management and Quality for the efficient and timely review of safety information at inVentiv Health Clinical
•Interact with clients and internal staff to provide advice and guidance on safety review issues; provide training and consultation to clients
•Assist Business Development for client development presentations that involve safety
reporting as a potential service; provide adequate input into client proposals
•Remain current on global pharmacovigilance requirements and disseminate any relevant changes to affected inVentiv Health Clinical personnel
•Identify training needs in pharmacovigilance and work with Training Group to implement appropriate training
•Advise senior management on adequate budget and resource planning
•May perform database administration functions

Requirements

•Bachelors Degree in a life science or nursing
•Ten years of relevant pharmaceutical or clinical research industry experience
•Excellent knowledge of ICH guidelines and regulations relating to pharmacovigilance
•Prior management and supervisory experience
•Demonstrate working knowledge of MS Office applications
•Excellent verbal and written communication skills
•Ability and willingness to travel (~ 20 %)


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