Drug Safety Senior Officer
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- Conduct global and local literature screening and assessment on a weekly basis.
- Manage post-marketing pharmacovigilance activities, including ICRSs, adverse events, and follow-up.
- Process safety cases in the Pharmacovigilance Database and ensure accurate reporting to EudraVigilance and relevant authorities.
- Translate pharmacovigilance-related content into English and liaise with Spanish Regulatory Authorities when needed.
- Support local QPPVs and the EU QPPV in operational and compliance-related activities.
- Stay up to date with global and local pharmacovigilance regulations.
- Contribute to the maintenance of the PSMF, SOPs, and the Pharmacovigilance Quality System.
- Prepare and review PSURs, RMPs, and other pharmacovigilance documentation.
- Provide support for Medical Information projects.
- Draft and review Pharmacovigilance Agreements.
- Prepare and deliver internal pharmacovigilance training. What we are looking for:
- At least 4 years of experience in pharmacovigilance.
- Strong experience in human medicinal product pharmacovigilance. Veterinarian Pharmacovigilance and Vigilance for medical devices are a plus.
- Good understanding of the full pharmacovigilance lifecycle.
- Hands-on experience with ICSR processing, literature review, EudraVigilance reporting, and post-marketing activities.
- Experience with PSURs, RMPs, PSMF, SOPs, and Pharmacovigilance Agreements.
- Good knowledge of EU pharmacovigilance regulations; Spanish local requirements are a plus.
- Strong organizational and communication skills.
- Professional fluency in English and Spanish. Why working at Asphalion?
- Flexible working schedule
- Friday until 15.30h.
- Homeoffice & Hybrid or Remote Model (You can be located anywhere in Portugal)
- 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 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.
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