Senior Drug Safety Manager

hace 4 semanas

Madrid, España TFS HealthScience A tiempo completo

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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