Pharmacovigilance & Safety Officer

il y a 3 jours

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.

  • Office Manager

    il y a 3 jours

    Leuven, Belgique Datadobi Temps plein

    -Location: Leuven, Belgium Responsibilities Include: **Office Management** - Organizing company events - Assisting the marketing department for EMEA and APJ marketing events - Coordinating the organization of quarterly and annual sales/operations meetings - Ensuring office efficiency and managing contact with all building-related suppliers (landlord,...

  • Health and Safety Coordinator

    il y a 1 jour

    Leuven, Belgique Medpace, Inc. Temps plein

    Job Summary: Our corporate activities are growing rapidly, and we are currently seeking a full-time **Health & Safety Coordinator - Preventieadviseur**to support our team and coordinate services at our office in Belgium, This office based position is located at our Leuven, Belgium facilities with main focus on lab & logistics as our prevention advisor...

  • Sustainability & Utilities Officer

    il y a 2 semaines

    Leuven, Belgique BENEO-Remy Temps plein

    **TOGETHER WE CONTRIBUTE TO BETTER NUTRITION AND HEALTH**: We are a global market leader in functional food ingredients for both humans and animals, with production sites in Germany, Belgium, Chile and Italy. With our worldwide distribution network, we market our ingredients in over 75 countries. BENEO is a member of the Südzucker Group. **Your...

  • EHS&S EMEA Coordinator

    il y a 2 semaines

    Leuven, Belgique Terumo Temps plein

    Job SummaryAs EHS&S Coordinator EMEA, you will provide expert support to the employer, leadership, and employees in the planning, development, and implementation of the EHS policy.Job Responsibilities Ensure EHS compliance across the EMEA region, aligned with internal standards and local legislation. Conduct risk assessments and support incident...

  • Project Manager Retail

    il y a 1 jour

    Leuven, Belgique AECOM Temps plein

    At AECOM, we’re delivering a better world. We believe infrastructure creates opportunity for everyone. Whether it’s improving your commute, keeping the lights on, providing access to clean water or transforming skylines, our work helps people and communities thrive. Our clients trust us to bring together the best people, ideas, technical expertise and...

  • Technical WH Coordinator

    il y a 2 semaines

    Leuven, Belgique Terumo Temps plein

    Job SummaryAs a Technical Warehouse Operator, you are responsible for the administrative and physical management of parts and materials under the control of the technical warehouse.Job Responsibilities Final Responsibilities Ensuring stock is always up-to-date and stored according to applicable agreements Maintaining order, cleanliness, and safety in...

  • Clinical Research Associate

    il y a 2 semaines

    Leuven, Belgique Terumo Temps plein

    Job SummaryAs a Clinical Research Associate (CRA), you will play a pivotal role in the execution and oversight of clinical trials. Acting as the bridge between the study sponsor and clinical sites, you will ensure the ethical and efficient conduct of studies, safeguard patient safety, and uphold data integrity and regulatory compliance. From study start-up...

  • International Corporate Counsel

    il y a 2 semaines

    Leuven, Belgique Integrated DNA Technologies (IDT) Temps plein

    **Purpose statement**: The International Corporate Counsel provides legal support to the business in the EMEA and APAC markets to all areas and functions of the corporation including Trade Compliance, Corporate Governance, Commercial Transactions, Human Resources, Environmental Health & Safety, Facilities, Shipping, Purchasing, Information Systems, Marketing...

  • Administrative assistant | Dutch/French

    il y a 2 semaines

    Leuven, Belgique Inizio Engage XD Temps plein

    We’re looking for a dynamic and hands-on administrative assistant for a pharmaceutical company based in Flanders, Leuven.The core responsibilities of this role is to ensure the highly effective operation of all aspects of the office, to support the Head of Commercial BeNeLux, his team and the HR team of BeNeLux in all administrative tasks required and PO...

  • Accounting Administrator

    il y a 2 semaines

    Leuven, Belgique Integra Temps plein

    Integra is a leading petrochemical trading group with a unique combination of global reach, fast and effective communication, technical skills, market knowledge and an absolute commitment to customer and supplier partnerships. See more at: For its Distribution Business, office to be based in the Leuven area in Belgium, Integra SA is looking for an Accounting...