They are AstraZeneca. More than 62,000 employees strong, they have a presence in over 100 countries across six continents. They represent a diverse gathering of cultures. Yet there is one element that connects us all: helping people live healthier lives. Every day, we work together discovering, developing, manufacturing and marketing a powerful pipeline that addresses six major areas of healthcare: cancer, cardiovascular, gastrointestinal, infection, neuroscience, and respiratory and inflammation. In 2009 alone, our worldwide sales totaled $32.8 billion. Each year, they invest an average of over $4 billion in R&D, where more than 11,000 people are focused on bringing medical solutions to millions.
Post: Patient Safety Compliance & Support Scientist/Senior Scientist
Job Description:
* Ensure compliance with global and local procedural documents and local implementation of Patient Safety objectives, policies, processes and procedures
* Contributes to the development of local quality control processes
* Lead in-depth quality reviews of data, reports and regulatory submissions
* Identifies, with the assistance of stakeholder departments, areas of agreement requiring modification and manages that change.
* Compile regional and global compliance data for adverse event reporting Provide analysis and trending of compliance data and communicate to customers monthly
* Monitor compliance with global and local procedural documents, licensing agreements and regulations
* Assesses licensing partner's Pharmacovigilance capabilities and processes.
* Serve as a knowledge resource on adverse event reporting internal to Patient Safety staff as well as to AZ personnel in areas outside of Patient Safety
* Participate in regulatory inspections and internal audits
* Lead or contribute to the development and implementation of new safety-related systems, processes and procedures across Regions
* Take ownership for a local or global process with empowerment to represent the region
* Support a performance-driven culture
* Maintain knowledge of the Company disease and therapeutic areas for marketed drugs and drugs in development
* Demonstrate working knowledge of FDA regulations relevant to Patient Safety
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Candidate profile:
* Qualified to degree level in biosciences or an equivalent healthcare or pharmaceutical industry background, with proven competence in patient safety/clinical development
* Proven technical competence, with an ability to balance this with industry standards to achieve business goals
* Proven analytical skills
* Demonstrable leadership skills, able to resolve conflict
* Able to work with autonomy
* Able to work effectively as part of a cross-functional or global team
* Understanding of Patient Safety regulatory obligations
* Able to represent AstraZeneca externally where required
* Able to acquire and assimilate knowledge in different disciplines, disease and therapeutic areas
* Proven communication skills and knowledge of cultural diversity
* Able to influence whilst maintaining independent and objective views
* Maintains high ethical standards, including a commitment to AstraZeneca values and behaviors
* Good attention to detail
* Good time management
Additional Information:
Location: DE, Wilmington
Education: B.Pharm, M.Pharm, B.Sc, M.Sc
Functional Area: R&D
End Date: 10th Sept. 2011
Job ID: 602342
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