Medical Director Drug Safety- Cv
AstraZeneca (Delaware, Delaware)

This job posting has expired.

You may wish to try a search for Medical Director Drug Safety- CV

Or visit the FlipDog home page
 

External Summary of Primary Responsibilities: Description: Drug Safety physicians are involved in all safety surveillance activities, including medical review of individual safety cases and cumulative case listings, the production of periodic reports, signal-detection and SERM activities, and setting the safety standards and strategy for clinical development in accordance with the Clinical Project Operating model. These individuals must ensure that all safety surveillance activities are conducted to the highest ethical and safety standards in compliance with GCP and regulatory requirements. The person ensures the ongoing safety evaluation of a product or group of products by providing Drug Safety medical expertise and judgment to safety surveillance and clinical development activities, including ongoing patient risk management. The job-holder can expect to get broad international exposure to other functions involved in the R&D process within AZ, get an overview of how strategic direction is set within Clinical Drug Safety and how decisions are made during a drug development] regarding the emerging safety profile of a product during its life-cycle. The principal responsibilities for Drug Safety Physicians are summarized below. Principal Responsibilities: The general responsibilities are those for the Associate Medical Director Drug Safety, 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 Drug Safety colleagues. It is also expected that the job-holder will have Global Drug Safety Physician (GDSP) responsibility for one or more products. (i) Provide medical expertise and judgment throughout the case-handling process with medical review of individual cases and cumulative line listings (ii) Provide medical expertise and judgment to all Surveillance activities, including periodic report production/review, signal detection and SERM activities (iii) Provide Drug Safety medical 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 surveillance contributions for one or more products in accordance with the Clinical Project Operating Model and 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 Clinical Drug Safety objectives, policies, procedures and processes (viii) Maintain knowledge of the company disease and therapeutic areas for marketed drugs and drugs in development As a Global Drug Safety Physician: (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 Director to bring potential safety issues to the attention of the Global Product Team (x) Ensure consistency of Drug Safety medical input for the assigned product or products Internal and External Contacts/Customers · Clinical Drug Safety personnel, of 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
Position reports to Senior Safety Medical Director for CV
· Direct Reports - none · Indirect Reports – none

Responsibilities

Requirements – Education and Experience · Medical degree · At least 2 years of clinical experience post-registration · 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/Clinical Drug Safety 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 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 Behaviours · 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 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