Lead SAP-Software-Engineering
vor 2 Wochen
The Senior PV Scientist acts as the global lead for Pharmacovigilance activities within the Safety department, overseeing PV Scientist(s) assigned to their designated products. The responsibilities will be around the following task areas :
- Leading the signal management process (i.e., signal detection, signal tracking, signal documentation, facilitating decisions regarding signals and safety risk, etc.) for assigned product(s)
- Evaluating the safety data and signals as part of ongoing pharmacovigilance activities. Includes synthesis of data from multiple sources and authoring signal evaluation reports
- Leading the signaling review process and product Safety Signaling Team meetings as well as cross functional project meetings
- Leading the process for responding to safety questions from regulatory authorities
- Providing strategic input to the authoring of regulatory documents such as PSURs, DSURs, PADERs, Addendum to Clinical Overview
- Leading the development of Pharmacovigilance Plans, Risk Evaluation and Mitigation Strategy Plans (REMS), and Risk Management Plans (RMPs) including providing safety input to post authorization safety studies (PASS) and additional risk minimization measures
- Leading the development of the strategy for medical and scientific literature review for safety information
- Providing safety leadership to regulatory submissions in collaboration with the Global Safety Officer
- Maintaining an up to date understanding of relevant global safety regulations and guidelines
- Collaborating with Global Safety Officers and other Safety MDs for assigned investigational programs including clinical trial activities (protocol review, ICF review, etc.), safety committee management, data analysis, signal detection, ad hoc requests and other product activities, as assigned
- Leading initiatives for process improvement and consistency regarding aggregate reporting, clinical trial safety oversight, signal management and responding to ad hoc safety questions
In order to be considered for the role, the selected candidate must have :
- Master degree or degree in Life Sciences or related field
- 8+ years work experience in PV incl. strong experience in safety signal management and aggregate safety reports
- Strong pharmacovigilance and drug development foundation, including knowledge of applicable clinical trial safety regulations and post-marketing safety regulations
- Ability to work with complex clinical data to produce robust assessments of safety data
- Familiarity of pharmacoepidemiology definitions and their use in pharmacovigilance is desirable for working with safety science research activities
- Knowledge of common data processing software as well as of common safety database systems
- Strong written communication skills in English
The selected candidate will be part of a dynamic team and actively contribute to the discovery, development and delivery of innovative therapies to improve the lives of patients.
#J-18808-Ljbffr-
Lead SAP-Software-Engineering
vor 3 Wochen
Zug, Schweiz TN Switzerland VollzeitUnser Kunde ist ein wirtschaftlich stabiles Schweizer Unternehmen. Eine interne IT-Abteilung mit einem Team von rund 30 Personen ist für die wichtige und spannende Aufgabe verantwortlich, dass die Systeme jederzeit funktionieren.Geboten wird Ihnen:Ein zukunftsorientiertes Arbeitsumfeld, in dem Sie Ihr kreatives Potenzial voll ausschöpfen könnenMitarbeit...
-
Software Engineering Manager, ML
vor 2 Wochen
Zug, Schweiz TN Switzerland VollzeitAre you excited about the future of AI technology? Are you passionate about delivering value and maximizing the impact of R&D investment? Thomson Reuters is seeking a hands-on engineering manager to guide the delivery of cutting-edge AI solutions from concept to production.At Thomson Reuters Labs, we experiment, we build, we deliver. We support the...
-
Software Engineering Manager, ML
Vor 2 Tagen
Zug, Zug, Schweiz Thomson Reuters VollzeitAre you excited about the future of AI technology? Are you passionate about delivering value and maximizing the impact of R&D investment? is seeking a hands-on engineering manager to guide the delivery of cutting-edge AI solutions from concept to production. At Thomson Reuters Labs,we experiment, we build, we deliver. We support the organization and our...
-
Software Engineering Manager, ML
vor 3 Wochen
Zug, Schweiz Thomson Reuters VollzeitAbout the RoleIn this opportunity as Software Engineering Manager, AI you will:Foster a culture of innovation, growth, and continuous improvementOwn the delivery of business-critical features for high value, customer facing applicationsPromote efficient collaboration between scientists and engineers on a project basisOperate with urgency and manage change at...
-
Software Engineering Manager, ML
Vor 2 Tagen
Zug, Zug, Schweiz Thomson Reuters VollzeitAbout the Role In this opportunity as Software Engineering Manager, AI you will: Foster a culture of innovation, growth, and continuous improvement Own the delivery of business-critical features for high value, customer facing applications Promote efficient collaboration between scientists and engineers on a project basis Operate with...
-
SAP GTS Expert
Vor 7 Tagen
Zug, Zug, Schweiz Talentana AG VollzeitA talented Global Trade Specialist is needed by Talentana AG to lead the design and implementation of SAP GTS solutions for export control and global trade compliance.The successful candidate will work closely with business stakeholders to analyze requirements and develop effective solutions.Responsibilities include designing and optimizing SAP GTS...
-
Software Development Project Lead
Vor 6 Tagen
Zug, Zug, Schweiz Nicoll Curtin VollzeitJob DescriptionAs a skilled Software Development Project Lead, you will play a key role in leading, organizing, and managing Software Development projects at Nicoll Curtin.The team develops a suite of cloud-based applications that directly impact the company's core revenue-generating stream. The applications are deployed on Azure using Docker and Kubernetes...
-
Software Engineering Manager, ML, Zug
vor 4 Wochen
Zug, Schweiz TN Switzerland VollzeitSocial network you want to login/join with:About the RoleIn this opportunity as Software Engineering Manager, AI you will:Foster a culture of innovation, growth, and continuous improvementOwn the delivery of business-critical features for high value, customer facing applicationsPromote efficient collaboration between scientists and engineers on a project...
-
Global SAP Finance and Operations Leader
Vor 7 Tagen
Zug, Zug, Schweiz Talentana AG VollzeitWe are seeking a Global SAP Finance and Operations Leader to join our team at Talentana AG. As a key player in the implementation of SAP S/4HANA, you will drive business transformation and optimize financial processes. This exciting opportunity is part of our company's commitment to innovation and excellence in finance and operations.About the PositionIn...
-
Teamlead Software Development
vor 3 Wochen
Zug, Schweiz TN Switzerland VollzeitYou lead the transformation of our Software team into a cutting-edge unit specializing in design to develop contemporary medical devices solutions in vacuum technology applications. You will apply SAFe / Agile methodologies, drive solution level thinking and system architecture, and stay updated on emerging technologies. In addition to your high-level...
-
Lead SAP Backend Developer
vor 3 Wochen
Zug, Schweiz TN Switzerland VollzeitLead SAP Backend Developer (80-100%) (m/w/d), ZugROCKEN hat mit Ihrer digitalen Rekrutierungslösung den Bewerbungsprozess massgeblich vereinfacht und setzt damit einen neuen, einheitlichen Standard. Wir verbinden Talente, Experten und Expertinnen in der gesamten Schweiz. Unser Netzwerk an etablierten Unternehmen stellen wir auf unserer ROCKEN Talent...
-
Project Leader and Vendor Manager
vor 3 Wochen
Zug, Schweiz Swisslinx VollzeitOn behalf of our client, a leading pharmaceutical company in Rotkreuz, Swisslinx is looking for a talented Project Leader and Vendor Manager for PCR Software Solutions. The company's Nobel-prize winning PCR Technology is in a phase of transformation and has seen huge growth during the Covid Pandemic. Our client is indeed looking for an experience Project...
-
Manager, Research Engineering
vor 1 Woche
Zug, Schweiz Thomson Reuters VollzeitAre you excited about the future of AI technology? Are you passionate about delivering value and maximizing the impact of R&D investment? Thomson Reuters Labs is seeking a hands-on engineering manager to guide the delivery of cutting-edge AI solutions from concept to production. At Thomson Reuters Labs, we experiment, we build, we deliver. We support the...
-
SAP GTS Specialist
vor 3 Wochen
Zug, Schweiz Talentana AG VollzeitTech Recruiter at Talentana | Work & Organisational PsychologistOur client, a global Swiss industrial company in the energy sector, is looking for a GTS Specialist. Join a dynamic and international environment where you can make an impact!What you'll doDesign and optimize SAP GTS solutions for export control and global trade complianceSupport and enhance SAP...
-
Senior Director Software
vor 4 Wochen
Zug, Schweiz Enersys VollzeitEnerSys is the global leader in stored energy solutions for industrial applications. We have over thirty manufacturing and assembly plants worldwide servicing over 10,000 customers in more than 100 countries. Worldwide headquarters are located in Reading, PA, USA with regional headquarters in Europe and Asia. We complement our extensive line of Motive Power...
-
SAP GTS Consultant, Zug
vor 3 Wochen
Zug, Schweiz TN Switzerland VollzeitSocial network you want to login/join with:Landis+Gyr is a leading global provider of integrated energy management solutions. We measure and analyze energy utilization to generate empowering analytics for smart grid and infrastructure management, enabling utilities and consumers to reduce energy consumption. Our innovative and proven portfolio of software,...
-
Head of Engineering
vor 1 Woche
Zug, Schweiz TAAL VollzeitWe are looking for a **Head of Engineering** **Role and Responsibilities** - Take active part in the development/coding activities - Line management of the Engineering team (more than 15 FTEs)- Manage performance and development of team members - Maintain and improve working environment with clear roles and accountabilities for all - Manage staffing &...
-
Lead protocol engineer
vor 3 Wochen
Zug, Zug, Schweiz Gora Network VollzeitGora Network is a leading data oracle on Algorand. We're working on the next generation of the data oracles to bring data of any complexity on any chain. You will be helping to lead our protocol team which is responsible for our core product. You will ensure your team is meeting project timelines and deliverables. Ensure that your team follows engineering...
-
Senior C#/.NET Software Engineer 100%
vor 3 Wochen
Zug, Schweiz TN Switzerland VollzeitSchleuniger GroupGegründet (1975) und mit Hauptsitz in Thun, Schweiz, ist Schleuniger ein globales Technologieunternehmen und ein innovativer Lösungsanbieter für die Kabelverarbeitungs- und Prüfindustrie. Lösungen von Schleuniger finden sich überall dort, wo präzise Verbindungen, maximale Produktivität, zuverlässige Datenrückverfolgbarkeit und...
-
Lead protocol engineer
Vor 2 Tagen
Zug, Zug, Schweiz Gora Network VollzeitGora Network is a leading data oracle on Algorand. We're working on the next generation of the data oracles to bring data of any complexity on any chain. You will be helping to lead our protocol team which is responsible for our core product. You will ensure your team is meeting project timelines and deliverables. Ensure that your team follows engineering...
