Drug Safety Senior Officer
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Be part of the future of drug safety at Asphalion We’re looking for a Drug Safety Senior 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
Main responsibilities:- Perform weekly global/local literature assessments.
- Efficiently manage post-marketing activities including 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 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:- +4 years experience in Pharmacovigilance departments, with strong exposure to post-marketing activities.
- Advanced IT level – (MS Office)
- Academic Degree in Life Science or Pharmacovigilance.
- Proactive, good communication, accurate, detail orientated, teamwork
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.
A professional, inclusive and high-performance work environment to develop your skills and grow your career. A great company culture built around Commitment, Quality, Teamwork, Adaptability, Innovation & Purpose-led.
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.
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