(Jo816) Director, Safety Science

(JO816) Director, Safety Science Barcelona, Catalonia (JO816) Director, Safety Science Barcelona Barcelona, Catalonia, ES This is what you will do:The Director, Safety Scientist plays a leadership role within Global Patient Safety organizing and mentoring safety scientists to actively evaluate, manage and strategize risk in collaboration with the GDS Medical Directors and cross-functional team members within the global regulatory frameworkYou will be responsible for:Leading risk management evaluation and resolution for assigned products and projects. Accountability for the following:Proven skill set for strategic leadership in a cross functional matrixOrganize,train and/or support junior safety scientists and fellows across multiple product portfolios and/or indicationsCo-lead activities related to new drug applications and other regulatory filingsRepresent global patient safety at regulatory inspections i. e. MHRA, FDA, EMA, etc. Lead analysis to identify and address changes in global regulations including updates to SOP and process documentationLeading activities to identify and address process gapsResponsible for vendor management and training including budgetsResponsible for overall project distribution across therapeutic areaAs needed represent GPS in global program teams and associated cross functional teams and/or projectsProactively provide guidance and educational training to GPS therapeutic teamsParticipate in ongoing safety data review and analysis for products in designated therapeutic areas. Responsible for Signal Review Meeting and Signal Management Team activities in collaboration with GPS Medical DirectorsResponsible for project managing and authoring of safety documents including PSUR, PBER, PADER, RMP, REMS, CSRs, and ad hoc requests in collaboration safety physicians. Responsible for authoring safety section in collaboration with team members on regulatory responses, IBs/CCDS, protocol, ICF review,Data Monitoring Committees reports and requests, and other documents, and provide the necessary quality control to ensure alignment with core safety position. Manage portfolio of products/projects related to risk management; assists Safety Physicians in the development of risk management strategy and activities for assigned productsYou will need to have:Advanced degree in a biologic/medical/clinical/nursing field: Pharmacist/PharmD, Nurse Practitioner or PhD with at least 7 years experience in drug safety and risk management within the pharmaceutical, biotech or CRO industryKnowledge and understanding of US and EU safety regulations pre- and post- marketingExperience with Risk Management and Minimization programsExperience preparing post marketing safety regulatory documents including PSURs,PBRERs and Risk Management PlansExperience with clinical development including risk/benefit analysis and safety assessmentStrong clinical, analytical, problem solving and scientific writing and communication skillsThe 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:Expertise with clinical and safety databasesExperience in MedDRA coding and search strategiesExcellent,independent judgment based on knowledge and expertiseStrong personal time-management and project-management skillsMastery of Microsoft Word, PowerPoint and ExcelWhen we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law. 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. #LI-EB1#LI-HYBRIDDate Posted09-Jan-2024Closing Date29-Apr-2024Welcome to hacendo.comkitempleo. es asks for your consent to use your personal data to:perm_identityperm_identity Personalised advertising and content, advertising and content measurement, audience research and services development (JO816) Director, Safety Science Barcelona Barcelona, Catalonia, ES This is what you will do:The Director, Safety Scientist plays a leadership role within Global Patient Safety organizing and mentoring safety scientists to actively evaluate, manage and strategize risk in collaboration with the GDS Medical Directors and cross-functional team members within the global regulatory frameworkYou will be responsible for:Leading risk management evaluation and resolution for assigned products and projects. Accountability for the following:Proven skill set for strategic leadership in a cross functional matrixOrganize,train and/or support junior safety scientists and fellows across multiple product portfolios and/or indicationsCo-lead activities related to new drug applications and other regulatory filingsRepresent global patient safety at regulatory inspections i. e. MHRA, FDA, EMA, etc. Lead analysis to identify and address changes in global regulations including updates to SOP and process documentationLeading activities to identify and address process gapsResponsible for vendor management and training including budgetsResponsible for overall project distribution across therapeutic areaAs needed represent GPS in global program teams and associated cross functional teams and/or projectsProactively provide guidance and educational training to GPS therapeutic teamsParticipate in ongoing safety data review and analysis for products in designated therapeutic areas. Responsible for Signal Review Meeting and Signal Management Team activities in collaboration with GPS Medical DirectorsResponsible for project managing and authoring of safety documents including PSUR, PBER, PADER, RMP, REMS, CSRs, and ad hoc requests in collaboration safety physicians. Responsible for authoring safety section in collaboration with team members on regulatory responses, IBs/CCDS, protocol, ICF review,Data Monitoring Committees reports and requests, and other documents, and provide the necessary quality control to ensure alignment with core safety position. Manage portfolio of products/projects related to risk management; assists Safety Physicians in the development of risk management strategy and activities for assigned productsYou will need to have:Advanced degree in a biologic/medical/clinical/nursing field: Pharmacist/PharmD, Nurse Practitioner or PhD with at least 7 years experience in drug safety and risk management within the pharmaceutical, biotech or CRO industryKnowledge and understanding of US and EU safety regulations pre- and post- marketingExperience with Risk Management and Minimization programsExperience preparing post marketing safety regulatory documents including PSURs,PBRERs and Risk Management PlansExperience with clinical development including risk/benefit analysis and safety assessmentStrong clinical, analytical, problem solving and scientific writing and communication skillsThe 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:Expertise with clinical and safety databasesExperience in MedDRA coding and search strategiesExcellent,independent judgment based on knowledge and expertiseStrong personal time-management and project-management skillsMastery of Microsoft Word, PowerPoint and ExcelWhen we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law. 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. #LI-EB1#LI-HYBRIDDate Posted09-Jan-2024Closing Date29-Apr-2024Welcome to hacendo.comkitempleo. es asks for your consent to use your personal data to:perm_identityperm_identity Personalised advertising and content, advertising and content measurement, audience research and services developmentdevicesdevices Store and/or access information on a deviceData preferencesYou can choose how your personal data is used. 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This site or app wants your permission to do the following:Site or appStore and/or access information on a deviceAdvertising presented to you on this service can be based on limited data, such as the website or app you are using, your non-precise location, your device type or which content you are (or have been) interacting with (for example, to limit the number of times an ad is presented to you).Create profiles for personalised advertisingInformation about your activity on this service (such as forms you submit, content you look at) can be stored and combined with other information about you (for example, information from your previous activity on this service and other websites or apps) or similar users. This is then used to build or improve a profile about you (that might include possible interests and personal aspects). Your profile can be used (also later) to present advertising that appears more relevant based on your possible interests by this and other entities.Use profiles to select personalised advertisingAdvertising presented to you on this service can be based on your advertising profiles, which can reflect your activity on this service or other websites or apps (like the forms you submit, content you look at), possible interests and personal aspects.Information about your activity on this service (for instance, forms you submit, non-advertising content you look at) can be stored and combined with other information about you (such as your previous activity on this service or other websites or apps) or similar users. This is then used to build or improve a profile about you (which might for example include possible interests and personal aspects). Your profile can be used (also later) to present content that appears more relevant based on your possible interests, such as by adapting the order in which content is shown to you, so that it is even easier for you to find content that matches your interests.Use profiles to select personalised contentContent presented to you on this service can be based on your content personalisation profiles, which can reflect your activity on this or other services (for instance, the forms you submit, content you look at), possible interests and personal aspects. This can for example be used to adapt the order in which content is shown to you, so that it is even easier for you to find (non-advertising) content that matches your interests.Information regarding which advertising is presented to you and how you interact with it can be used to determine how well an advert has worked for you or other users and whether the goals of the advertising were reached. For instance, whether you saw an ad, whether you clicked on it, whether it led you to buy a product or visit a website, etc. This is very helpful to understand the relevance of advertising campaigns.Information regarding which content is presented to you and how you interact with it can be used to determine whether the (non-advertising) content e. g. reached its intended audience and matched your interests. For instance, whether you read an article, watch a video, listen to a podcast or look at a product description, how long you spent on this service and the web pages you visit etc. This is very helpful to understand the relevance of (non-advertising) content that is shown to you.Understand audiences through statistics or combinations of data from different sourcesReports can be generated based on the combination of data sets (like user profiles, statistics, market research, analytics data) regarding your interactions and those of other users with advertising or (non-advertising) content to identify common characteristics (for instance, to determine which target audiences are more receptive to an ad campaign or to certain contents).Information about your activity on this service, such as your interaction with ads or content, can be very helpful to improve products and services and to build new products and services based on user interactions, the type of audience, etc. This specific purpose does not include the development or improvement of user profiles and identifiers.Content presented to you on this service can be based on limited data, such as the website or app you are using, your non-precise location, your device type, or which content you are (or have been) interacting with (for example, to limit the number of times a video or an article is presented to you).Vendors can use your data
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