At AstraZeneca, we make a difference every day by delivering life-changing medicines to millions of people globally. Our purpose is ambitious and so is our approach. Creating a more agile and inclusive environment means building an inspiring culture where we celebrate innovative thinking.

Our Patient Safety team sits within the Chief Medical Office; an integrated, enterprise-wide organisation dedicated to defining the benefit/risk assessment of our medicines across the life-cycle, acquiring and maintaining health authority approvals around the world. Our oncology pipeline, which includes novel combinations and modalities, provides a unique intellectual opportunity for Patient Safety staff. Our teams’ experience develops as our portfolio does!

As the  Medical Director, Patient Safety Physician you have a role in ensuring the safety of patients who take AstraZeneca medicines. This role is responsible for providing safety physician leadership to support project discussions within matrix teams and at governance boards, in order to ensure continuous evaluation of adverse events and other safety information in order to predict and manage the safety profile of drugs throughout their lifecycle. This might include updates to product safety information, along with the design and implementation of risk management initiatives.

Activities are likely to include, but are not limited to:

• Safety surveillance activities, including medical review of individual safety cases, safety signal detection and evaluation for your products, including collaboration with external safety teams.

• Evaluate safety data from pre-clinical and clinical studies, medical literature and other information sources, to characterise the safety profile of AstraZeneca medicines.

• Build and develop clear, concise documents to describe your safety evaluation; for discussion with business partners and to support product labelling updates or responses to regulatory agency requests.

• Medical review for aggregate periodic regulatory reports, such as the Periodic Benefit Risk Report

• Representing Patient Safety on cross-functional teams, including the need to provide input to address urgent and important safety issues.

• Provide patient safety contribution to global regulatory submissions for new medicines, formulations or indications.

• Contributing to strategic Patient Safety input to drug development and post-marketing programs

Essential Requirements

• Medical degree (eg MD, MBBS)

• Some clinical experience post-registration

• Experience within the pharmaceutical industry, either in drug safety / PV or another relevant industry function

• Intellectual curiosity and proven ability to learn new skills

• Ability to contribute successfully to teams

• Strong verbal and written communication skills

Desirable

• MSc/PhD in scientific field

• Drug Development/Patient Safety experience in clinical development programmes

• Experience of supervising Patient Safety colleagues

• A demonstrated ability to understand epidemiological data

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.