Senior Drug Safety Manager
2 semanas atrás
TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and Functional Service (FSP) solutions.Join Our Team as a Senior Drug Safety Manager, dedicated to our global Ophthalmology business unit. About this roleAs part of our Ophthalmology focussed Drug Safety Manager team you will working alongside passionate and innovative professionals to ensure our customers achieve their goals.Key Responsibilities Pharmacovigilance Oversight: Manage SAE handling in clinical trials and post-marketing, ensuring compliance with SOPs and regulatory requirements; review and approve safety cases, coding, and reconciliation. Leadership & Project Management: Lead safety-only projects and cross-functional initiatives; oversee departmental safety activities and ensure project execution aligns with legal and procedural standards. Process & Quality Management: Develop and maintain SOPs, templates, and safety processes; implement new procedures and validate safety-related systems. Regulatory Compliance: Stay updated on global pharmacovigilance regulations and ensure adherence across all safety operations. People Management: Line manage Drug Safety Unit staff, including coaching, mentoring, performance reviews, salary negotiations, and onboarding/training of new personnel. Administrative Duties: Approve time reports, travel expenses, and manage invoicing/revenue for assigned projects. Qualifications Extensive and proven Drug Safety Background. Adaptability & Independence: Thrive in fast-paced environments with shifting priorities; capable of working autonomously or within a matrix team structure. Scientific & Regulatory Knowledge: Strong grasp of medical terminology, therapeutic areas, GCP, ICH guidelines, pharmacovigilance legislation, and internal SOPs. Communication Skills: Excellent written and verbal communication, with the ability to clearly convey complex safety information. Technical Proficiency: Skilled in word processing; proficient with spreadsheets; presentation software experience is a plus. Leadership & Mentorship: Proven ability to lead, mentor, educate, and supervise Drug Safety personnel. Analytical Thinking: Demonstrates sound judgment and critical thinking in safety-related decision-making. What We OfferWe provide a competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment. You’ll be joining a team that values collaboration, innovation, and making a difference in the lives of patientsA Bit More About UsOur journey began over 25 years ago in Sweden, in the city of Lund. As a global CRO with the ultimate goal of ensuring patients’ safety and well-being, we provide biotechnology and pharmaceutical companies with tailored clinical development solutions. We currently operate in 17 countries across Europe, North America, Asia Pacific and the Middle East. Our core values of Trust, Quality, Flexibility and Passion are what make TFS Healthscience the successful company it is today. Our values shape our culture and work ethic. They reflect what we stand for and guide our organization. #Together we make a difference
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Clinical Safety Specialist
1 semana atrás
Lisbon, Portugal Cencora Tempo inteiroOur team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals...
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Global Safety Senior Manager
3 semanas atrás
Lisbon, Portugal Amgen Tempo inteiroGlobal Safety Senior Manager - QQPV Office Join to apply for the Global Safety Senior Manager – QQPV Office role at Amgen Join our team at AMGEN Capability Center Portugal , number 1 company in Best WorkplacesTM ranking in Portugal in 2024 (category 201-500 employees) by the Great Place to Work Institute. We have a team of over 500 talented people and more...
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Channel Partner Development
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Lisbon, Portugal Draeger Safety UK Ltd Tempo inteiroA Dräger é uma empresa internacional líder nos campos da tecnologia médica e da segurança. Desde 1889 os nossos produtos têm vindo a proteger e a salvar vidas em hospitais, bombeiros, serviços de salvamento, agências governamentais, minas e indústrias, com mais de 15.000 empregados em todo o mundo. Principais responsabilidades Desenvolver e...
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Clinical Study Manager
2 semanas atrás
Lisbon, Portugal VectorB2B - Drug Development Tempo inteiroVectorB2B is a private association formed between Portuguese private and public partners, with the aim to gather the scattered capacities of the academic and industrial shareholders in the sector of health biotechnology. VectorB2B aims to provide integrated services in drug discovery and screening, project design and implementation, clinical contract...
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Clinical Study Manager
2 semanas atrás
Lisbon, Portugal VectorB2B - Drug Development Tempo inteiroVectorB2B is a private association formed between Portuguese private and public partners, with the aim to gather the scattered capacities of the academic and industrial shareholders in the sector of health biotechnology. VectorB2B aims to provide integrated services in drug discovery and screening, project design and implementation, clinical contract...
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Clinical Study Manager
2 semanas atrás
Lisbon, Portugal VectorB2B - Drug Development Tempo inteiroVectorB2B is a private association formed between Portuguese private and public partners, with the aim to gather the scattered capacities of the academic and industrial shareholders in the sector of health biotechnology. VectorB2B aims to provide integrated services in drug discovery and screening, project design and implementation, clinical contract...
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Safety Coordinator
1 semana atrás
Lisbon, Portugal Iberojet Tempo inteiro#SomosÁvorisAtIberojet, an airline belonging to theÁvoris Corporación Empresarialgroup, we are seeking aSafety Coordinator (and Management System support)in Lisbon to perform the following primary duties:Assists ORBEST Safety Manager in matters regarding safety implementation in ORBEST; Ensures and coordinates that safety meetings are held according the...
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Senior Project Manager
3 semanas atrás
Lisbon, Portugal WANTED Executive SearchCareer AdvisorCoaching Tempo inteiroSenior Project Manager / Director of Works / Senior Civil Engineer – Hospitality/Resort Construction (Portugal)Location: Algarve/AlbufeiraEmployment Type: Full-time, Senior LevelOur client, an international company operating a portfolio of high-end luxury resorts in the Mediterranean region, is currently expanding its development footprint in Portugal. The...
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Senior Project Manager
3 semanas atrás
Lisbon, Portugal WANTED Executive Search⎮Career Advisor⎮Coaching Tempo inteiroSenior Project Manager / Director of Works / Senior Civil Engineer – Hospitality/Resort Construction (Portugal)Location : Algarve/AlbufeiraEmployment Type : Full-time, Senior LevelOur client , an international company operating a portfolio of high-end luxury resorts in the Mediterranean region, is currently expanding its development footprint in Portugal....
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Senior Project Manager
3 semanas atrás
Lisbon, Portugal WANTED Executive SearchCareer AdvisorCoaching Tempo inteiroSenior Project Manager / Director of Works / Senior Civil Engineer – Hospitality/Resort Construction (Portugal)Location: Algarve/AlbufeiraEmployment Type: Full-time, Senior LevelOur client, an international company operating a portfolio of high-end luxury resorts in the Mediterranean region, is currently expanding its development footprint in Portugal. The...
