Role: Senior Director, Patient Safety Biopharma Location: Barcelona, Spain At AstraZeneca, we deliver life-changing medicines to millions of people globally. Our purpose is ambitious and so is our approach. Crafting a more agile and inclusive environment means building an inspiring culture where we celebrate innovative thinking. Our strategy and ability to transform our medicines portfolio means we have a drug-development pipeline that presents incredible opportunities to push the boundaries of science. Faced with complex disease challenges, we focus on outstanding performance to drive the world's best and most progressive drug development programs.
We are looking for a Senior Director to join our Patient Safety Biopharma team in Barcelona, Spain. You will play a pivotal role in channeling our scientific capabilities to make a positive impact on patients' lives. You will help drive development of our innovative pipeline, redefining exciting science into valued new medicines and ensuring patients around the world can access them. You will be representing the voice of patients in the development, maintenance and use of our medicines. The core purpose of our Patient Safety organization is to add value to AstraZeneca products, provide clear science-based guidance for investigators and prescribers to safeguard patients as well as the success of our business.
Main Responsibilities:Develop objectives for Patient Safety in area of responsibility and ensure these are aligned to broader AstraZeneca goals and objectives.Be an SME for Pharmacovigilance regulations/mentorship, leading the Patient Safety Therapy Area.Represent and serve as a pharmacovigilance specialist in regulatory agency inspections.Share standard methodology across teams within and between Patient Safety Therapy Areas, partnering with other groups as needed.Lead Patient Safety input into Pharmacovigilance Agreements, managing alliance partners for assigned products; may lead due diligence activities.Provide strategic safety leadership for complex and groundbreaking projects to improve processes within Patient Safety and/or develop and introduce new technologies and approaches at the national, regional or global level.Build networks with other Patient Safety Therapy Areas/teams and external partners to learn about new developments, create opportunities and share best practices, such as benchmarking and Industry forums.Partner with Patient Safety Operational, Technology and Analytics to implement changes in Pharmacovigilance legislative landscape to prepare appropriate resources and skill sets to address the future.Serve as deputy for Patient Safety Therapy Area VP.Participate as a member of the Patient Safety Biopharma Leadership team.Minimum Requirements:Master's degree or equivalent qualification in relevant scientific field.Experience in managing a scientific team.Extensive proven experience in Pharmacovigilance field.Knowledge of relevant legislation and developments in the Pharmaceutical industry.Experience in either writing Risk Management Plans and assessing risk mitigation activities or in translating preclinical safety experience to man.Experience leading strategic projects (Drug and non-drug).Demonstrated ability to influence key partners within and outside of the company.Demonstrated proficiency with both written and verbal communication.Previous experience managing PV Scientists in drug development.Desirable:PhD in relevant scientific field.Strong network and reputation within the business and industry.Extensive knowledge of the latest technical and regulatory expectations.Employer of Choice: We offer a competitive Total Reward program including a market driven base salary, bonus and long term incentive. We have a generous paid time off program and a comprehensive benefits package. AstraZeneca aligns with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
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