Associate Director, Safety Scientist, Global Patient Safety
hace 1 mes
This is what you will do:The Associate Director, Safety Scientist plays a leadership role within Global Patient Safety (GPS) to actively evaluate and manage risk in collaboration with the GPS Medical Director(s) and cross-functional team members within the global regulatory framework.You will be responsible for:Managing safety scientist activities across multiple product portfolios and/or indications.Organizing, training and/or supporting junior safety scientists and fellows.Supporting activities related to new drug applications and other regulatory filings.Representing global patient safety at regulatory inspections e.g., MHRA, FDA, EMA, etc.Leading gap analysis to ensure alignment with changes in global regulations.Strategizing and drafting responses to regulatory inquiries on product safety issues inclusive of defining MedDRA search strategy.Representing GPS in global program teams and associated cross-functional teams and/or projects as needed.Proactively providing guidance and educational training to GPS therapeutic teams.Responsible for Signal Review Meeting and Signal Management Team activities in collaboration with GPS Medical Directors.Performing Signal Surveillance activities for respective programs in collaboration with GPS Medical Directors.Project managing and authoring safety documents including PSUR, PBER, PADER, RMP, REMS, CSRs, and ad hoc requests in collaboration with GPS Medical Directors.Authoring safety sections, in collaboration with team members, on regulatory responses, IBs/CCDS, protocols, ICFs, Data Monitoring Committee reports and requests, and other documents, and providing the necessary quality control to ensure alignment with core safety position.Managing portfolio of products/projects related to risk management; assisting GPS Medical Directors in the development of risk management strategy and activities for assigned products.Contributing to ongoing process enhancement for safety analytics and reporting, such as developing standard procedures and templates.Assisting GPS Medical Directors to oversee risk minimization activities including tracking of activities as needed.May be directed by the line function to support initiatives outside of their projects.You will need to have:Bachelor's degree in a biologic/medical/clinical/nursing field.At least 5 years experience in drug safety and risk management within the pharmaceutical, biotech, or CRO industry.Knowledge and understanding of US and EU safety regulations pre- and post-marketing.Experience with Risk Management and Minimization programs.Experience preparing post-marketing safety regulatory documents including PSURs, PBRERs, and Risk Management Plans.Experience with clinical development including risk/benefit analysis and safety assessment.Strong clinical, analytical, problem-solving, and scientific writing and communication skills.Ability to interact effectively with people of multiple disciplines and cultures both within and outside the company on a global basis.Expertise with Microsoft Word, PowerPoint, SharePoint, and Excel.The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation, to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.We would prefer for you to have:Advanced degree in a biologic/medical/clinical/nursing field preferred: Pharmacist/PharmD, Nurse Practitioner, or PhD.Expertise with clinical and safety databases.Experience in MedDRA coding and search strategies.Excellent, independent judgment based on knowledge and expertise.Strong personal time-management and project-management skills.Mastery of Microsoft Word, PowerPoint, and Excel.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.
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Barcelona, España Https:Www.Energyjobline.ComSitemap.Xml A tiempo completo.This is what you will do:The Associate Director, Safety Scientistplays a leadership role within Global Patient Safety (GPS) to actively evaluate and manage risk in collaboration with the GPS Medical Director(s) and cross-functional team members within the global regulatory framework.You will be responsible for:Managing safety scientist activities across...
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Associate Director, Patient Safety Scientist
hace 1 mes
Barcelona, España Astrazeneca Gmbh A tiempo completoJob Title: Associate Director, Patient Safety Scientist Career Level - E Introduction to role: Join our Biopharmaceuticals Business Unit as an Associate Director, Patient Safety Scientist. You will work collaboratively with the Global Safety Physician (GSP) and Senior Patient Safety Scientist, reviewing safety data and related documents for potential safety...
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Barcelona, España Astrazeneca Gmbh A tiempo completo.This is what you will do:The Associate Director, Safety Scientist plays a leadership role within Global Patient Safety (GPS) to actively evaluate and manage risk in collaboration with the GPS Medical Director(s) and cross-functional team members within the global regulatory framework.You will be responsible for:Managing safety scientist activities across...
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Barcelona, España Astrazeneca Gmbh A tiempo completo.This is what you will do:The Associate Director, Safety Scientist plays a leadership role within Global Patient Safety (GPS) to actively evaluate and manage risk in collaboration with the GPS Medical Director(s) and cross-functional team members within the global regulatory framework.You will be responsible for:Managing safety scientist activities across...
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Associate Director, Safety Scientist, Global Patient Safety
hace 3 semanas
Barcelona, España Astrazeneca Gmbh A tiempo completo.This is what you will do: The Associate Director, Safety Scientist plays a leadership role within Global Patient Safety (GPS) to actively evaluate and manage risk in collaboration with the GPS Medical Director(s) and cross-functional team members within the global regulatory framework. You will be responsible for: Managing safety scientist activities across...
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Barcelona, España Astrazeneca A tiempo completo.Associate Director, Senior Patient Safety Scientist Oncology Location: Barcelona, Spain (on-site) 3 days working from the office and 2 days working from home. 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 work...
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Barcelona, España AstraZeneca GmbH A tiempo completoThis is what you will do:The Associate Director, Safety Scientist plays a leadership role within Global Patient Safety (GPS) to actively evaluate and manage risk in collaboration with the GPS Medical Director(s) and cross-functional team members within the global regulatory framework.You will be responsible for:Managing safety scientist activities across...
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Barcelona, España Astrazeneca Gmbh A tiempo completoThis is what you will do: The Associate Director, Safety Scientist plays a leadership role within Global Patient Safety (GPS) to actively evaluate and manage risk in collaboration with the GPS Medical Director(s) and cross-functional team members within the global regulatory framework.You will be responsible for: Managing safety scientist activities across...
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Barcelona, España Astrazeneca Gmbh A tiempo completoThis is what you will do: The Associate Director, Safety Scientist plays a leadership role within Global Patient Safety (GPS) to actively evaluate and manage risk in collaboration with the GPS Medical Director(s) and cross-functional team members within the global regulatory framework.You will be responsible for: Managing safety scientist activities across...
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Barcelona, España Astrazeneca Gmbh A tiempo completoJob Title: Associate Director, Patient Safety ScientistCareer Level - EIntroduction to role:Join our Biopharmaceuticals Business Unit as an Associate Director, Patient Safety Scientist. You will work collaboratively with the Global Safety Physician (GSP) and Senior Patient Safety Scientist, reviewing safety data and related documents for potential safety...
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Associate Director, Patient Safety Scientist
hace 2 semanas
Barcelona, España Astrazeneca A tiempo completoWould 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 work together to deliver innovative medicines to patients across global boundaries. We make an impact and find solutions to challenges. We do this with integrity,...
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Associate Director, Patient Safety Scientist
hace 3 semanas
Barcelona, España Astrazeneca A tiempo completoWould 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 work together to deliver innovative medicines to patients across global boundaries. We make an impact and find solutions to challenges. We do this with integrity,...
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Barcelona, España https:www.energyjobline.comsitemap.xml A tiempo completoThis is what you will do: The Associate Director, Safety Scientist plays a leadership role within Global Patient Safety (GPS) to actively evaluate and manage risk in collaboration with the GPS Medical Director(s) and cross-functional team members within the global regulatory framework. You will be responsible for: Managing safety scientist activities across...
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Barcelona, España Https:Www.Energyjobline.ComSitemap.Xml A tiempo completoThis is what you will do:The Associate Director, Safety Scientist plays a leadership role within Global Patient Safety (GPS) to actively evaluate and manage risk in collaboration with the GPS Medical Director(s) and cross-functional team members within the global regulatory framework.You will be responsible for: Managing safety scientist activities across...
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Barcelona, España Https:Www.Energyjobline.ComSitemap.Xml A tiempo completoThis is what you will do: The Associate Director, Safety Scientist plays a leadership role within Global Patient Safety (GPS) to actively evaluate and manage risk in collaboration with the GPS Medical Director(s) and cross-functional team members within the global regulatory framework.You will be responsible for: Managing safety scientist activities across...
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Associate Director, Patient Safety Scientist
hace 3 meses
Barcelona, España Astrazeneca A tiempo completo.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 work together to deliver innovative medicines to patients across global boundaries. We make an impact and find solutions to challenges. We do this with integrity,...
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Associate Director, Safety Scientist, Global Patient Safety
hace 4 semanas
Barcelona, Barcelona, España Https:Www.Energyjobline.ComSitemap A tiempo completoJob SummaryThis is a leadership role within Global Patient Safety (GPS) where you will actively evaluate and manage risk in collaboration with the GPS Medical Director(s) and cross-functional team members within the global regulatory framework.Key ResponsibilitiesManage safety scientist activities across multiple product portfolios and/or...
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Barcelona, España Https:Www.Energyjobline.ComSitemap.Xml A tiempo completoThis is what you will do:The Associate Director, Safety Scientistplays a leadership role within Global Patient Safety (GPS) to actively evaluate and manage risk in collaboration with the GPS Medical Director(s) and cross-functional team members within the global regulatory framework.You will be responsible for:Managing safety scientist activities across...
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Associate Director, Senior Patient Safety Scientist
hace 6 meses
Barcelona, España AstraZeneca A tiempo completoAt AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation - ultimately providing employees with the opportunity to work across teams, functions and even the globe. Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal...
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Barcelona, España Https:Www.Energyjobline.ComSitemap.Xml A tiempo completoThis is what you will do:The Associate Director, Safety Scientistplays a leadership role within Global Patient Safety (GPS) to actively evaluate and manage risk in collaboration with the GPS Medical Director(s) and cross-functional team members within the global regulatory framework.You will be responsible for:Managing safety scientist activities across...
