Safety Periodic Reports Lead
il y a 1 jour
Safety Periodic Reports Lead Join Excelya as a Safety Periodic Reports Lead. About the Job Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand. This role is an exciting opportunity to lead the development of safety periodic reports within our dynamic and ambitious Safety team. You will contribute to high-quality pharmacovigilance services while ensuring compliance with industry regulations and standards in a stimulating professional environment. Main Responsibilities: Contribute to the preparation, coordination, and maintenance of product safety profiles within the Global Safety department, in compliance with internal procedures. Support the planning and delivery of periodic safety reports (DSURs, PSURs, Clinical Overviews) in collaboration with Safety Periodic Reports Leads and PV Project Leads. Draft and coordinate ad hoc expert safety reports, responses to Health Authority questions, and other safety data analyses. Lead and update Risk Management Plans (RMPs) for assigned products. Monitor and oversee the external service provider responsible for the coordination and drafting of periodic reports. Ensure proper tracking and submission of safety reports to Health Authorities. Participate in regulatory impact assessments related to periodic reporting and safety requirements. Contribute to project teams and Medical Safety Teams as a pharmacovigilance representative when required. About You Experience: Strong background in pharmacovigilance and experience in writing safety periodic reports. Education: Minimum Master's degree (Bac +5) in Life Sciences, Pharmacy, or a related field. Skills: Excellent analytical skills with a keen attention to detail; proficient knowledge of regulatory guidelines (e.g., GVP, ICH) and best practices in pharmacovigilance. Languages: Fluency in French and in English (both written and spoken). Soft Skills: Exceptional communication and interpersonal skills; able to work effectively in a team and manage relationships across departments. Benefits At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare. We are a young, ambitious health company representing 900 Excelyates, driven to become Europe’s leading mid-size CRO with the best employee experience. Our one-stop provider service model offers full-service, functional service provider, and consulting, enabling you to evolve through diverse projects. We are a small team that values natural talents, pushes boundaries with audacity, and nurtures your potential, allowing you to contribute fully to our shared mission. Seniority level Associate Employment type Full-time Job function Science Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Excelya by 2x #J-18808-Ljbffr
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Safety Periodic Reports Lead
il y a 1 jour
Saclay, France Excelya Group Temps pleinAbout the Job Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand. This role is an exciting opportunity to lead the development of safety periodic reports within our dynamic and ambitious Safety...
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Safety Periodic Reports Lead
il y a 5 jours
Saclay, Île-de-France Excelya Temps pleinAbout the JobJoin Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.This role is an exciting opportunity to lead the development of safety periodic reports within our dynamic and ambitious Safety...
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Safety Periodic Reports Lead
il y a 5 jours
Saclay, Île-de-France Excelya Temps pleinAbout the JobJoin Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.This role is an exciting opportunity to lead the development of safety periodic reports within our dynamic and ambitious Safety...
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Safety Periodic Reports Lead
il y a 5 jours
Saclay, Île-de-France EXCELYA Temps pleinAbout the JobJoin Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.This role is an exciting opportunity to lead the development of safety periodic reports within our dynamic and ambitious Safety...
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Lead, Safety Periodic Reports
il y a 1 jour
Saclay, France Excelya Temps pleinAn innovative healthcare company in Saclay is seeking a Safety Periodic Reports Lead to oversee the development of safety reports. The role requires a strong background in pharmacovigilance, fluency in French and English, and a relevant Master's degree. Candidates will work in a collaborative environment, contributing to high-quality services and regulatory...
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Lead, Safety Periodic Reports
il y a 1 jour
Saclay, France Excelya Group Temps pleinA leading health company in Saclay is seeking a Pharmacovigilance Specialist to lead the development of safety periodic reports. The ideal candidate has a strong background in pharmacovigilance and a Master's degree in Life Sciences or Pharmacy. You will contribute to high-quality pharmacovigilance services, ensuring compliance with industry regulations...
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Safety Database Administrator
il y a 1 jour
Saclay, France Excelya Temps pleinSafety Database Administrator Join Excelya's Pharmacovigilance team as a Safety Database Administrator. In this pivotal role, you will ensure the effective management and operation of our safety database, contributing to the overall quality and compliance of our pharmacovigilance activities. Why Join Us? At Excelya, we are committed to excellence in...
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Safety Database Administrator
il y a 2 jours
Saclay, Île-de-France EXCELYA Temps pleinHybridOperations, PV & SafetyFull timeSaclay, Île-de-France, FranceOVERVIEWDescriptionWhy Join Us?At Excelya, we are committed to excellence in healthcare, and we invite you to be part of our dedicated team where your expertise can make a significant impact.As a young, ambitious health company with over 900 talented professionals, we strive to be Europe's...
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Safety Database Administrator
il y a 2 jours
Saclay, Île-de-France Excelya Temps pleinWhy Join Us?At Excelya, we are committed to excellence in healthcare, and we invite you to be part of our dedicated team where your expertise can make a significant impact.As a young, ambitious health company with over 900 talented professionals, we strive to be Europe's leading mid-size CRO, delivering the best employee experience. Our integrated service...
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Safety Database Administrator
il y a 2 jours
Saclay, Île-de-France Excelya Temps pleinWhy Join Us?At Excelya, we are committed to excellence in healthcare, and we invite you to be part of our dedicated team where your expertise can make a significant impact.As a young, ambitious health company with over 900 talented professionals, we strive to be Europe's leading mid-size CRO, delivering the best employee experience. Our integrated service...
