Medical Director- Patient Safety- Respiratory and Infection/GI Therapy Area: AstraZeneca Pharmaceuticals

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AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. But we're more than one of the world's leading pharmaceutical companies. At AstraZeneca, we're proud to have a unique workplace culture that inspires innovation and collaboration. Here, employees are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity. We have received many honors, including:

• Fortune World's Most Admired Companies list (2009)
• Woman Engineer Magazine's 18th Annual "Top 50 Employers" (2008)
• The Times Top 100 Graduate Employers (2007-2008)
• CEO Cancer Gold Standard Reaccreditation, CEO Roundtable on Cancer (2008 & 2009)
• 100 Best Companies for Working Mothers by Working Mother Magazine (2002 - 2008)
• 100 Best Companies to Work For in America by Fortune Magazine* (2008) *Only large pharmaceutical company included on the list
• Diversity MBA Magazine Top 50 Companies in Diversity Leadership (2008)
• Men's Fitness Top 15 Fittest Companies in America (2008)
• The Scientist Best Places to Work in Industry (2008)
• Fit-Friendly Company Award, American Heart Association (2007)
• Top Employer, Science Magazine (2002 - 2007)

Medical Director- Patient Safety- Respiratory and Infection/GI Therapy Area

Job Summary

Responsibilities

Reports to: Therapy Area Safety Leader, Clinical Patient Safety-Respiratory and Infection/GI Therapy Area



The statements made in this job description are intended to describe the general nature and level of work being performed by those persons assigned to this job. These statements are not intended to be an exhaustive list of all responsibilities, duties and skills required of these people, nor will they necessarily all apply for every individual assigned to this job.

Description:
Patient Safety physicians are involved in all safety surveillance activities, including the medical review of individual adverse event cases and cumulative case line listings, the production of periodic aggregate reports, signal-detection and safety evaluation and review activities, and setting safety standards and strategy for clinical development in accordance with AstraZeneca standards and clinical operating model. These individuals must ensure that all safety surveillance activities are conducted to the highest ethical and safety standards in compliance with International Conference on Harmonization - Good Clinical Practice guidelines and regulatory authority requirements worldwide.
The Patient Safety Physician ensures the ongoing safety evaluation of a product or group of products by providing safety expertise and medical judgment to safety surveillance and clinical development activities, including patient risk management. The job-holder can expect to gain broad international exposure to other functions involved in the R&D process within AZ and get an overview of how strategic direction is set and decisions are made within Clinical Patient Safety regarding the emerging safety profile of a product.
The principal responsibilities for the Patient Safety Physician are summarized below.

Principal Responsibilities:
The responsibilities listed below are general, though it is expected that given greater knowledge and experience such responsibilities may be carried out at a higher level in the business, with greater cross-functional interaction and through supervision of Patient Safety colleagues. Depending on the role, the job-holder may have US and/or global responsibilities for one or more products.
(i) Provide medical expertise and judgment throughout the case-handling process with medical review of individual adverse event cases and cumulative case line listings
(ii) Provide medical expertise and judgment to all surveillance activities, including periodic report production/review, signal detection and safety evaluation and review activities
(iii) Provide safety expertise and judgment in the production and maintenance of Patient Risk Management Plans, as appropriate
(iv) Provide medical expertise and judgment to enable high-quality and timely responses to safety queries
(v) Provide scientific and safety-related contributions for one or more products in support of AstraZeneca business plans and priorities
(vi) Support a performance-driven culture
(vii) Ensure compliance with global and local procedural documents and local implementation of department objectives, policies, procedures and processes
(viii) Maintain knowledge of the Company's disease and therapeutic areas for marketed drugs and drugs in development


(ix) Ensure ongoing evaluation of the overall safety profile for one or more products, serving as the product safety expert, working in partnership with the Medical Science Physicians in a cross-functional environment around product safety matters.
(x) Ensure consistency of safety and medical input for the assigned product or products

Impact on business results through
· The quality and timeliness of safety data management
· Providing medical expertise to the cross-functional life-cycle management of products

Internal and External Contacts/Customers
· Clinical Patient Safety personnel, at all levels, across the Regions
· Clinical Development personnel mainly within the Region, but across the Regions on projects where required
· Regulatory Affairs and other AstraZeneca personnel mainly within the Region
· External opinion leaders and experts as required

Reporting Relationship
· Direct Reports - none
· Indirect Reports - none





Qualifications

Requirements - Education and Experience
· Medical degree
· At least 2 years of clinical experience post-registration/certification
· High level of medical competence, with an ability to balance this with industry standards to achieve business goals
· Two or more years of Drug Development/Pharmacovigilance experience obtained while working in industry and/or academia
· A thorough knowledge of the pharmaceutical industry, especially clinical research and global regulatory requirements and practices governing expedited and periodic safety reporting, signal generation, safety evaluation and risk management activities is preferred

Skills and Capabilities
· General medical/therapeutic area knowledge
· Ability to acquire and assimilate knowledge in different disciplines, disease and therapeutic areas
· Ability to influence whilst maintaining independent and objective views
· Excellent communication, interpersonal and organizational skills
· Attention to detail
· Delivery focus

Organizational Behaviors
· Integrity and high ethical standards
· Excellent team-working skills
· Ability to appreciate diversity and work as equals with global and cross-functional teams
· Customer-focused
· Demonstrable leadership skills in directing the work of others

Problem solving
· Manage a wide range of problems, requiring complex judgments and innovative solutions, needing well-developed conceptual thinking and thus having a high level of business risk management
· Access external resources for advice and respond to external events by adjusting plans or developing new approaches to working

Leadership Capabilities:

· Passion for Customers
· Thinks Strategically
· Acts Decisively
· Drives Performance
· Works Collaboratively
· Develops People and Organization

We want you to build a balanced life at AstraZeneca. Your career is just one part of that. We offer competitive salaries, rewards and recognitions for your invaluable time and efforts. We also bring you all the things you need to for your life outside of your work:

• generous health and welfare benefits
• flexible scheduling
• child care programs
• learning and development opportunities
• fitness centers
• and other personal conveniences

At AstraZeneca, we put people first. Whether it's the patients we help or the employees who make everything we do possible.

AstraZeneca is an equal opportunity employer.