Associate Director Physician

Contract length: 6 months

Location: Alderley Park or Cambridge

Patient 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 safety evaluation and review meeting (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 Good Clinical Practices (GCP) and regulatory requirements globally.

These persons ensure the ongoing safety evaluation of a product or group of products by providing Patient 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 Patient Safety and how decisions are made during a drug development regarding the emerging safety profile of a product during its life cycle.

Accountabilities/Responsibilities

- Provide medical expertise and judgment throughout the case-handling process with medical review of individual cases and cumulative line listings
- Provide medical expertise and judgment to all surveillance activities, including periodic report production/review, signal detection, SERM activities, the local labeling process, and the production and maintenance of Patient Risk Management Plans
- Provide medical expertise and judgment to enable high-quality and timely responses to safety queries
- 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
- Support a performance-driven culture
- Ensure compliance with global and local procedural documents and local implementation of Patient Safety objectives, policies, procedures and processes
- Maintain knowledge of the company disease and therapeutic areas for marketed drugs and drugs in development

Requirements - Education and Experience

- Medical degree or equivalent
- A number of years of prove clinical experience post-registration/certification
- High level of medical competence, with an ability to balance this with industry standards to achieve business goals
- Significant number of years of drug development and/or Pharmacovigilance experience obtained while working in the pharmaceutical industry and/or academia

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