Senior Drug Safety Manager

TFS HealthScience; Madrid; Presencial; EUR 60.000 - 90.000; Jornada completa

Descripción de la vacante

Join TFS HealthScience as a Senior Drug Safety Manager focusing on the global Ophthalmology business unit. This role involves overseeing pharmacovigilance activities, managing safety operations, and developing compliance standards while leading a dedicated team. You will play a crucial role in ensuring the safety of patients through rigorous oversight of clinical trials and post-marketing processes, all within a supportive and innovative company culture.

Servicios

Competitive compensation package

Comprehensive benefits

Opportunities for personal and professional growth

Formación

• Proven Drug Safety background with regulatory knowledge.
• Excellent written and verbal communication.
• Demonstrates sound judgment and critical thinking.

Responsabilidades

• Manage SAE handling in clinical trials and ensure compliance.
• Lead safety-only projects and oversee safety activities.
• Develop and maintain SOPs and validate safety systems.

Conocimientos

Pharmacovigilance

Leadership

Communication

Analytical Thinking

Adaptability

Educación

Extensive Drug Safety Background

Strong grasp of medical terminology

Herramientas

Word processing software

Spreadsheets

Presentation software

Descripción del empleo

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 SeniorDrug Safety Manager , dedicated to our global Ophthalmology business unit.

About this role

As 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 Offer

We 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 patients

A Bit More About Us

Our 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