Senior Drug Safety Officer – Remote Clinical Trials

Asphalion; España; Remote; EUR 45.000 - 60.000; Vollzeit

Benefits dieser Stelle

Flexible scheduling

Homeoffice & Hybrid or Remote Model

Zusammenfassung

Asphalion is seeking a Drug Safety Senior Officer to join our fast-moving, international team in Spain. You will support pre-marketing safety activities, manage AESIs, SAEs, and SUSARs, and ensure timely reporting via EudraVigilance and MHRA portals.

Ideal candidates have 4+ years in pharmacovigilance, a Life Science or PV degree, and strong IT skills with MS Office. We offer hybrid/remote work within Spain and ongoing training.

Qualifikationen

• +4 years experience in Pharmacovigilance departments, with strong exposure to premarketing activities.
• Advanced IT level – MS Office.
• Academic Degree in Life Science or Pharmacovigilance.
• Proactive, good communication, accurate, detail orientated, teamwork.

Aufgaben

• Support clinical trial safety activities in a pre-marketing environment.
• Manage, assess and follow up AESIs, SAEs, and SUSARs from clinical studies into the Safety database.
• Ensure timely and compliant case processing and reporting through EudraVigilance and MHRA portal.
• Support pharmacovigilance and safety submissions at EU and ROW level, ensuring compliance with requirements.
• Perform reconciliations with clinical databases to ensure data consistency.
• Manage safety-related queries and follow up with stakeholders for timely resolution.

Kenntnisse

Proactive attitude

Communication skills

Attention to detail

Teamwork

Ausbildung

Life Science or Pharmacovigilance degree

Tools

MS Office

Jobbeschreibung

Asphalion is seeking a Drug Safety Senior Officer to join our fast-moving, international team in Spain. You will support pre-marketing safety activities, manage AESIs, SAEs, and SUSARs, and ensure timely reporting via EudraVigilance and MHRA portals.

Ideal candidates have 4+ years in pharmacovigilance, a Life Science or PV degree, and strong IT skills with MS Office. We offer hybrid/remote work within Spain and ongoing training.