Medical Director, Patient Safety Physician

Introduction to role:
Are you ready to make a meaningful impact on patients lives? We are seeking a Medical Director, Patient Safety Physician to join our dedicated Research & Development team in Biopharmaceuticals R&D. This role is responsible for the Clinical Safety strategy for assigned AstraZeneca drug projects and products throughout all stages of development and/or when on the market. You will be responsible for continuous efficient evaluation of adverse event and all other safety information in order to predict and manage the safety profile of compounds in clinical development and marketed products.

Accountabilities:

As a Medical Director, Patient Safety Physician, you will be involved in all safety surveillance activities, may include medical review of individual safety cases (providing medical expertise and judgement), signal detection, evaluation and SIRC activities for all products in area or responsibility. You will provide medical input to regulatory supporting documentation for labelling updates and contribute to the preparation of licensing agreements in therapeutic area of responsibility. You will also participate in AZ internal meetings with project focus and external regulatory and non-regulatory meetings including those with consultants and other companies such as licensing partners.

Essential Skills/Experience:
- Medical degree (eg MD, MBBS)
- At least 2 years of clinical experience post-registration preferred
- High level of medical competence
- Up to 11-13 years of Patient Safety experience (with clear evidence of delivery). 5 years of team handling experience
- Total 15+ years of experience
- A thorough knowledge of the pharmaceutical/ biopharmaceutical industry, especially clinical research and global regulatory requirements and practices governing expedited and periodic safety reporting, signal generation, safety evaluation and risk management activities

- Leadership skills: Commitment to Customers and Integrity, Strategic Leadership, Acts Decisively, Drives Accountability, Works Collaboratively, Develops People and Organisation
- Technical skills: Drug Development Experience and Application of Disease and TA knowledge, Integrative thinking, Excellence in pharmacovigilance, Patient Benefit risk assessment
- Core skills: Conceptual thinking, Influencing, Initiative, Innovation, Business relationship management