Sr Director, Global Safety Operations

Sr Director, Global Safety OperationsClinical safety expert needed to manage internal and external safety teamsIf you have clinical experience having been involved in clinical trials, QA Audit and or safety this challenging position will provide fulfillment and satisfaction. Have you ever managed a team/ Are you a natural leader? If so please review the Responsibilities and requirements.RESPONSIBILITIES:
Operational oversight of Global Safety Department including budget management, operational metrics, compliance, case management teams as well as operational interface with vendor and corporate alliance partnerships. This position will be dealing with a high volume of AE’s and a product that is exploding upon the market. Your focus will be true operational global safety. You will be working both domestically and internationally. Position will manage direct reports associated with operations staff including areas of clinical safety and pharmacovigilance case management, compliance and training. Responsibilities of the position include ensuring that case processing and data quality meet global regulatory compliance needs including audit support. This position will closely align with representatives in other departments to aid in needed alignment of common activities. Effective collaboration with Senior Directors of Global Safety and Pharmacovigilance is critical to ensure effective use of department resources.REQUIREMENTS:
At minimum, bachelors degree and 12 years of applicable experience or masters degree and eight years of experience required; Pharmaceutical industry experience required; Prior drug safety, clinical, regulatory, or similar experience required; Strong management and interpersonal communication skills mandatory; Demonstrated track record of managing staff and projects in a high-growth, regulated environment; Prior experience in resource planning and management; Demonstrated skill in strategic planning activities; Demonstrated success in managing outsourced vendor partnerships and contracts; GXP compliance experience desirable. The incumbent must be familiar with regulations and guidance to facilitate optimal operations that are in compliance with these standards. You may be required to travel 10% of the time.
REQUIREMENTS
Please see job description.