Pharmacovigilance & Safety Officer

il y a 2 semaines

Leuven, Belgique Excelya Temps plein

HybridOperations, PV & SafetyPart time
Leuven, Flanders, Belgium
OVERVIEW
Description
Join Excelya, where Audacity, Care, and Energy define who we are and how we work.
We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.
This role is an exciting opportunity to join our dynamic and ambitious Pharmacovigilance and Safety team. Rooted in a long-standing tradition of excellence in pharmacovigilance, our department continues to evolve rapidly, offering a vivid, forward-thinking work environment that embraces innovation and growth
**Mains Responsibilities**:
The position involves performing as Local Contact Person responsible for Pharmacovigilance for Belgium and the Netherlands and participating in local/global projects within the Pharmacovigilance (PV) and Safety department.
Work in several aspects of pharmacovigilance shall be expected, such as
- Performs local literature search/review or quality control on results, maintain local journal/conference lists
- handles case reports, complaints, queries (from collection to reporting to Client/Authorities)
- Prepares/reviews aggregate reports (e.g. PSURs/PBRERs)
- Prepares Risk Management Plans
- Assists in handling/monitoring additional risk minimisation activities
- Maintenance of the PV System
- Participate in/conduct trainings
- Participate in audits/inspections

**Requirements**:
**About You**:
At Excelya, taking audacious steps is encouraged, so we’re looking for individuals who are ready to grow with us and share our values.
**Education**: University Degree in Life Sciences (Pharmacy or related field).
**Experience**: Minimum 2 years of relevant experience in pharmacovigilance, preferably within a global working environment.
**Skills**: Strong organizational skills with high attention to detail; proven ability to work both independently and collaboratively in a demanding multinational context; goal
- and client-oriented mindset; demonstrated success in handling diverse tasks efficiently
**Technical**: Proficient in MS Windows and MS Office; experience with safety databases and/or possession of an Eudravigilance certificate considered an asset.
**Languages**: Excellent command of English (written and spoken); proficiency in French and Dutch. Knowledge in German is considered an advantage.
**Soft-Skills**: Self-motivated, strong communication skills, and a true team player.

**Benefits**:
Why Join Us?
At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.
Here’s what makes us unique
We are a young, ambitious health company representing 900 Excelyates, driven to become Europe’s leading mid-size CRO with the best employee experience. Our one-stop provider service model offering full-service, functional service provider, and consulting enables you to evolve through diverse projects. Working alongside preeminent experts, you will help improve scientific, operational, and human knowledge to enhance the patient's journey.
Excelling with care means benefiting from an environment that values your natural talents, pushes boundaries with audacity, and nurtures your potential, allowing you to contribute fully to our shared mission.

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