Would you like to use your drug safety or pharmacovigilance experience to make a difference to the lives of millions of patients across the world? If you would, please read on! 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.
What you will do 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
Location : Barcelona
Salary : Competitive + Excellent Benefits
Next steps, if the role looks suitable please apply!
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