Drug Safety Officer

hace 3 semanas


Madrid, España ASPHALION A tiempo completo

Be part of the future of drug safety at Asphalion We're looking for a
Drug Safety Officer
ready to embrace new challenges in a fast-moving, international environment. If you thrive on precision and want to make a real impact, we'd love to have you on our team
Key Responsibilities:
Perform weekly global/local literature assessments.
Efficiently manage Individual Case Safety Reports (ICSRs), Adverse Events (AEs), and follow-up activities.
Manage cases through the Pharmacovigilance Database and report accurately to European authorities via EudraVigilance.
Translate relevant pharmacovigilance information into English and liaise with Spanish Regulatory Authorities.
Provide support to local and EU Qualified Persons for Pharmacovigilance (EUQPPv).
Stay informed about updates in global and local pharmacovigilance regulations.
Oversee the maintenance of the PSMF and Asphalion's Pharmacovigilance System (SOPs).
Prepare and review PSURs, RMPs, DSURs, and ACOs with attention to detail.
Offer expert medical advice and support Medical Information projects.
Draft and review Pharmacovigilance agreements and provide strategic insights.
Prepare and conduct internal Pharmacovigilance training sessions.
If you're passionate about ensuring drug safety and eager to grow professionally, join us at Asphalion and be part of a team at the forefront of pharmacovigilance innovation
Requirements:
+2 years experience in Pharmacovigilance departments.
Fluent in English (C1) & Spanish
Advanced IT level – (MS Office)
Academic Degree in Life Science and Pharmacovigilance.
Proactive, good communication, accurate, detail orientated, teamwork
Why working at Asphalion?
Permanent contract.
Flexible working schedule - Friday until 15.30h.
Homeoffice & Hybrid or Remote Model
(You can be located anywhere in Spain)
Wide variety of projects, new challenges and experiences.
Training and personal development program.
English lessons.
A professional, inclusive and high-performance work environment to develop your skills and grow your career. A great company culture built around Passion, Flexibility, Commitment, Quality & Companionship.
A highly & dynamic working environment with employees from more than 15 nationalities.
Our people and their well-being are our priority: Physical, psychological and emotional well-being programme.
Internal activities & RSC Activities


  • Drug Safety Officer

    hace 7 horas


    Madrid, España Oracle A tiempo completo

    Drug Safety Officer-2300043G **Applicants are required to read, write, and speak the following languages***: English, Spanish **Preferred Qualifications** - Cerner Enviza, an Oracle company, is a leading global healthcare consulting firm and trusted advisor to many of the world’s top pharmaceutical, biotech, and medical device & diagnostic companies. By...

  • Drug Safety Officer

    hace 3 semanas


    Madrid, España ASPHALION A tiempo completo

    Be part of the future of drug safety at Asphalion We're looking for a¿No sabe con seguridad qué habilidades necesitará para esta oportunidad? Simplemente lea la descripción completa a continuación para obtener una idea clara de los requisitos del candidato.Drug Safety Officerready to embrace new challenges in a fast-moving, international environment. If...

  • Drug Safety Associate

    hace 6 días


    Madrid, España Parexel A tiempo completo

    **Job Purpose**: The Drug Safety Associate will provide technical and process-related support to drug safety management (clinical trial and post-marketed) and medical monitoring activities, ensuring compliance with relevant regulations and Standard Operating Procedures (SOPs). **Key Accountabilities: - ** **Drug Safety Support** Assist in development of...


  • 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...

  • Drug Safety Trainee

    hace 3 semanas


    Madrid, España ASPHALION A tiempo completo

    ASPHALION is aninternational Regulatory, Scientific & Safety consultancy companyfounded in 2000. Its strong track record has made ASPHALION a reference in the international healthcare sector and a key stakeholder in the implementation of new regulatory standards. ASPHALION’s experts have delivered solutions to over 1,000 Pharmaceutical, Biotechnological...

  • Veterinary PV Lead

    hace 1 semana


    madrid, España Vetpharma A tiempo completo

    A global veterinary health company based in Spain is looking for a Pharmacovigilance Manager to oversee the drug safety function. You will lead a team to ensure compliance with regulations and manage adverse events associated with veterinary medicines. The ideal candidate holds a relevant degree and has at least 3 years of experience in a similar role, with...

  • Global Safety Lead

    hace 2 semanas


    Madrid, España Dechra A tiempo completo

    A global veterinary pharmaceuticals company is seeking a Senior Principal Scientist in Global Safety.Asegúrese de enviar su solicitud rápidamente para maximizar sus posibilidades de ser considerado para una entrevista. Lea la descripción completa del puesto a continuación.This remote role requires a PhD and extensive experience in drug...


  • Madrid, España Insud Pharma A tiempo completo

    Overview: Ensuring legal and regulatory compliance with the pharmacovigilance regulations and Good Pharmacovigilance Practices (GVP). As Drug Safety Team Leader, coordinating part of the staff and the activities related to PV system, QMS, safety from clinical trials, aggregate reports, safety variations. As EU & UK deputy of the qualified person responsible...

  • Health & Safety Officer

    hace 2 semanas


    Madrid, España Brambles Group A tiempo completo

    CHEP helps move more goods to more people, in more places than any other organization on earth via our 300 million pallets, crates and containers. We employ 11,000 people and operate in more than 55 countries. Through our pioneering and sustainable share-and-reuse business model, the world’s biggest brands trust us to help them transport their goods more...

  • Safety physician

    hace 2 semanas


    Madrid, España SRG A tiempo completo

    We are currently looking for an experienced Safety Physician to support ongoing and upcoming clinical development projects. This role requires a highly competent professional with strong expertise across Clinical Safety and Pharmacovigilance, contributing both operationally and strategically. Key responsibilities will include:Providing comprehensive safety...