Associate Director of Medical Services
Illinois
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Date Posted: |
03/06/09 |
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Date Available: |
Immediate
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Descriptions: |
We are a boutique firm specializing in medical device and biotechnology. Our client is a global leader in the industry.
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Responsibilities: |
Strategically develops, implements and maintains business and systems within medical safety surveillance. Responsible for at least 3 of the following: therapeutic area, major functional areas, or multiple teams. Defines the boundaries of accepted risk tolerance within the department, negotiates with interdepartmental counterparts on projects having potential for significant financial, legal, or regulatory implication. Identifies projects requiring decisions by senior or executive level management. Serves as liaison with other divisions and companies to assure the appropriate and efficient provision of information within established co-marketing, co-promotional, and in-licensing guidelines. Establishes strategic planning for the medical safety surveillance department, and the departmental achievement of initiatives to meet goals and plan.
Accountable for managing departmental budget, negotiating budgetary needs with Operations and Finance, and identifying and projecting future expenditures. Ensures worldwide reporting compliance and delivery of reports to affiliates and EUQP in a timeframe which allows timely international reporting. Provides back-up coverage to Medical Safety Surveillance director.
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Qualifications: |
• 1 year clinical experience in related area and 5 years of pharmacovigilance experience required.
• Adverse event processing and reporting requirements, global regulations and their application • Software and systems supporting safety surveillance activities: AEGIS/ARISg, MedDRA, Windows Word, Excel, PowerPoint • Adverse event database structure and information retrieval; knowledge of drug safety profiles • Technical writing and authoring of SOPs/process documents, CAPAs, audit responses, metrics, and management reports • Subject Matter expert in interpreting and applying health authority guidelines and regulations.
• Maintains in-depth understanding in political and legal climate of Global Pharmacogivilance, including industry practice related to the promotion of pharmaceuticals and subsequent training of sales representatives.
• Interprets issues in promotional climate and educates staff on the potential impact on and application in Medical Review.
apply to business issues
• Ensures success of organizational initiatives by aligning GMS solutions to key business processes.
• Ensures that the introduction of new technology or systems takes into account the impact of organizational processes.
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Salary Range & Benefits: |
Full relocation
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Contact Information
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To Apply: |
Interested candidates apply to:
Nancy Rowe
nrowe1@aol.com
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