Lavori attuali relativi a Serm Associate Medical Director - Siena - Glaxosmithkline
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Serm Associate Scientific Director
1 mese fa
Siena, Italia GSK A tempo pieno**Site Name**: UK - London - New Oxford Street, Canada - Ontario - Mississauga, Italy - Siena, Poznan Grunwaldzka, Warsaw Rzymowskiego 53 **Posted Date**: Sep 25 2024 As SERM Associate Scientific Director you will provide scientific expertise in the safety evaluation and risk management of key GSK assets in clinical development and/or the post-marketing...
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Executive Director, SERM Head
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Siena, Italia 12371 GSK Vaccines S.r.l. A tempo pienoPosition summary The Executive Director, Safety Evaluation & Risk Management (SERM) Head is accountable to lead SERM (Safety Evaluation & Risk Management) medical and scientific staff and define and drive the strategy and vision of clinical safety and pharmacovigilance activities in alignment with Global Safety business strategies. Competencies ...
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Siena, Toscana, Italia Glaxosmithkline A tempo pienoAbout the Role:The Global Clinical Safety and Pharmacovigilance Director, Serm Head will lead the Safety Evaluation and Risk Management (SERM) medical and scientific staff and define the strategy and vision of clinical safety and pharmacovigilance activities in alignment with Global Safety business strategies.Key Responsibilities:Translate strategic plans...
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Associate Director, In-Process Analytics
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Siena, Toscana, Italia Glaxosmithkline A tempo pienoJob Title: Associate Director, In-Process AnalyticsWe are seeking an experienced Associate Director to lead our In-Process Analytics team in Italy. The successful candidate will be responsible for developing and implementing in-process analytical methods to support vaccine development.Key Responsibilities:Lead a team of experts in in-process analytics to...
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Siena, Italia GSK A tempo pieno**Site Name**: Wavre, Italy - Siena, Mississauga **Posted Date**: Aug 30 2024 GSK has an inspiring ambition: by uniting science, technology and talent we aim to positively impact the health of 2.5 billion people over the next ten years. We will get ahead of disease together with our R&D approach of focusing on the science of the immune system, human...
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Junior Pharmacovigilance Associate
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Siena, Italia Philogen A tempo pieno**Location: Siena - Italy** *** **Department: Clinical** *** **Junior Pharmacovigilance Associate** Philogen S.p.A. would like to hire a Junior Pharmacovigilance Associate. The role will report directly to the Responsible of Pharmacovigilance. - Collaboration in the assessment, triage and management of SAEs and SUSAR submission (e.g. CIOMS-I form...
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Associate Director, In-Process Analytics
1 mese fa
Siena, Italia Glaxosmithkline A tempo pienoSite Name: Italy - SienaPosted Date: Sep 26 2024We create a place where people can grow, be their best, be safe, and feel welcome, valued, and included.We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.We embrace modern work practises;...
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Associate Director, In-Process Analytics
1 mese fa
Siena, Italia Glaxosmithkline A tempo pienoSite Name: Italy - SienaPosted Date: Sep 26 2024We create a place where people can grow, be their best, be safe, and feel welcome, valued, and included.We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.We embrace modern work practises;...
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Medical Writing Asset Lead
2 mesi fa
Siena, Italia Glaxosmithkline A tempo pienoSite Name: Belgium-Wavre, Italy - SienaPosted Date: Sep 6 2024Job purpose: Are you looking for a highly visible medical writing role that broadens your project management capabilities? If so, this Medical Writing Asset Lead role could be an ideal opportunity to consider.As a Medical Writing Asset Lead, you will lead therapy area specific medical writing...
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Associate Director, In-Process Analytics
1 mese fa
Siena, Italia Glaxosmithkline A tempo pienoSite Name: Italy - SienaPosted Date: Sep 26 2024We create a place where people can grow, be their best, be safe, and feel welcome, valued, and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.We embrace modern work practises;...
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Associate Director, In-Process Analytics
1 mese fa
Siena, Italia Glaxosmithkline A tempo pienoSite Name: Italy - Siena Posted Date: Sep 26 2024 We create a place where people can grow, be their best, be safe, and feel welcome, valued, and included.We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.We embrace modern work practises;...
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Medical Writing Asset Lead
2 mesi fa
Siena, Italia GSK A tempo pieno**Site Name**: Belgium-Wavre, Italy - Siena **Posted Date**: Sep 6 2024 **_ Job purpose:_** ***: **Are you looking for a highly visible medical writing role that broadens your project management capabilities? If so, this Medical Writing Asset Lead role could be an ideal opportunity to consider.**: ***: **As a Medical Writing Asset Lead, you will lead...
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Statistics Director
2 mesi fa
Siena, Italia GSK A tempo pieno**Site Name**: UK - London - New Oxford Street, Amsterdam, Collegeville TSA, Rockville Biopharm, Siena, Stevenage, Waltham, Wavre **Posted Date**: Aug 29 2024 At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and delivering transformational...
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Lead, Bioassay And Sample Management
2 settimane fa
Siena, Italia Csl Seqirus A tempo pienoThe Lead; Bioassay and Sample Management (L-BSM) is accountable for ensuring the on-time delivery of sample data and end-to-end central laboratory management across the global Clinical Development portfolio of CSL Clinical Trials.As the L-BSM you will establish CSL's laboratory management strategy, processes and standards, support the selection and oversees...
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Lead, Bioassay and Sample Management
3 settimane fa
Siena, Italia CSL Seqirus A tempo pienoThe Lead; Bioassay and Sample Management (L-BSM) is accountable for ensuring the on-time delivery of sample data and end-to-end central laboratory management across the global Clinical Development portfolio of CSL Clinical Trials.As the L-BSM you will establish CSL’s laboratory management strategy, processes and standards, support the selection and...
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Lead, Bioassay and Sample Management
3 settimane fa
siena, Italia CSL Seqirus A tempo pienoThe Lead; Bioassay and Sample Management (L-BSM) is accountable for ensuring the on-time delivery of sample data and end-to-end central laboratory management across the global Clinical Development portfolio of CSL Clinical Trials. As the L-BSM you will establish CSL’s laboratory management strategy, processes and standards, support the selection and...
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Lead, Bioassay And Sample Management
1 settimana fa
Siena, Italia Csl Seqirus A tempo pienoThe Lead; Bioassay and Sample Management (L-BSM) is accountable for ensuring the on-time delivery of sample data and end-to-end central laboratory management across the global Clinical Development portfolio of CSL Clinical Trials.As the L-BSM you will establish CSL's laboratory management strategy, processes and standards, support the selection and oversees...
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Lead, Bioassay And Sample Management
7 giorni fa
Siena, Italia Csl Seqirus A tempo pienoThe Lead; Bioassay and Sample Management (L-BSM) is accountable for ensuring the on-time delivery of sample data and end-to-end central laboratory management across the global Clinical Development portfolio of CSL Clinical Trials.As the L-BSM you will establish CSL's laboratory management strategy, processes and standards, support the selection and oversees...
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Lead, Bioassay and Sample Management
4 settimane fa
Siena, Italia CSL Behring A tempo pienoThe Lead; Bioassay and Sample Management (L-BSM) is accountable for ensuring the on-time delivery of sample data and end-to-end central laboratory management across the global Clinical Development portfolio of CSL Clinical Trials. As the L-BSM you will establish CSL’s laboratory management strategy, processes and standards, support the selection and...
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Lead, Bioassay and Sample Management
1 settimana fa
Siena, Italia CSL Seqirus A tempo pienoThe Lead; Bioassay and Sample Management (L-BSM) is accountable for ensuring the on-time delivery of sample data and end-to-end central laboratory management across the global Clinical Development portfolio of CSL Clinical Trials.As the L-BSM you will establish CSL’s laboratory management strategy, processes and standards, support the selection and...
Serm Associate Medical Director
2 mesi fa
Site Name: Italy - SienaPosted Date: Aug 9 2024We create a place where people can grow, be their best, be safe, and feel welcome, valued, and included.
We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.The SERM, Associate Medical Director will provide medical and scientific expertise in the safety evaluation and risk management of key GSK assets in clinical development and/or the post-marketing setting.He/She will ensure scientifically sound review and interpretation of data and management of safety issues and escalate safety issues identified through the safety review process to senior management and safety governance as appropriate.
The SERM, Associate Medical Director will make recommendations for the further characterization, management, and communication of safety risks.The SERM, Associate Medical Director will also focus on efficiency and effectiveness to meet the needs of our Patients and HCPs, supporting the pharmacovigilance and benefit-risk management of the assigned portfolio of GSK global assets to ensure Patient Safety globally.In this role you will…Responsible for signal detection and evaluation activities for assigned products.Drives production of regulatory periodic reports and associated documentation and RMPs globally according to the agreed process and timelines; advises on content of regulatory period reports (in partnership with the product physician).Authors the SERM safety contribution to global regulatory submissions.Supports and facilitates safety governance/SRTs in the clinical development and post marketing settings by assisting in the establishment and operation of cross-functional teams in any SERM to detect and address product safety issues and ensures that risk-reduction strategies are implemented appropriately in clinical study protocols and/or product labelling.Leads or participates in cross-functional process initiatives and/or Process Workstreams to drive efforts to improve adherence to regulations, data standards, quality, and efficiency.Presents complex issues to senior staff members at the GSK Senior Governance Committees.Why you?Qualifications Skills:Medical Doctor (physician), with additional relevant medical or scientific post-graduate qualifications.Pharmacovigilance experience relating to Safety Evaluation and Risk Management, encompassing both clinical development and post-marketing activities.Knowledge/experience of international pharmacovigilance requirements (e.g., ICH, GVP modules, CIOMS initiatives) and drug development and approval processes.Closing Date for Applications – September 15th, 2024Please take a copy of the Job Description, as this will not be available post closure of the advert.When applying for this role, please use the 'cover letter' of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above.#LI-Hybrid #J-18808-Ljbffr
