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
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 ( experience with Argus, eVeReport is a plus).
Ensure timely and compliant case processing and reporting through
EudraVigilance and MHRA portal
.
Support and contribute to
pharmacovigilance and safety submissions at EU and ROW level
, ensuring compliance with applicable local and global requirements.
Perform
reconciliations with clinical databases
to ensure consistency and completeness of safety data.
Manage
safety-related queries
and follow up with relevant stakeholders to ensure accurate and timely resolution.
Work with
eCRF data
as part of safety data review, follow-up, and reconciliation activities.
Ensure appropriate
filing of pharmacovigilance and clinical safety documentation in the eTMF
, according to study requirements and internal procedures.
Generate and review
line listings (LLs)
and contribute to the analysis of safety data outputs.
Prepare, review, and maintain
Safety Management Plans (SMPs)
in line with study and client requirements.
Contribute to




Annual Safety Reports (ASR) elaboration
.
Work closely with
sponsors, regulatory teams, and cross-functional
stakeholders.
Draft and review
Pharmacovigilance Agreements
and provide strategic safety input.
Support internal training and contribute to continuous improvement of pharmacovigilance processes.
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 premarketing activities.
Advanced IT level – (MS Office)
Academic Degree in Life Science or Pharmacovigilance.
Proactive, good communication, accurate, detail orientated, teamwork
Why working at Asphalion?
Adaptable working schedule - Friday until *h.
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.
#J-*-Ljbffr

📌 Drug Safety Senior Officer (Barcelona)
🏢 Asphalion
📍 Barcelona