Why Join Us?

At Excelya, we are committed to excellence in healthcare, and we invite you to be part of our dedicated team where your expertise can make a significant impact.

As a young, ambitious health company with over 900 talented professionals, we strive to be Europe's leading mid-size CRO, delivering the best employee experience. Our integrated service model enables you to engage in diverse projects, working alongside industry experts to enhance scientific knowledge and improve the patient journey.

About the Job

We are seeking a Safety Database Administrator to join our Pharmacovigilance team. In this pivotal role, you will ensure the effective management and operation of our safety database, contributing to the overall quality and compliance of our pharmacovigilance activities.

Main Responsibilities:

About the Job

Rejoignez Excelya en tant que Chef de Projet Pharmacovigilance et jouez un rôle clé dans l’optimisation et la gestion des activités de pharmacovigilance au sein de nos programmes de recherche. En intégrant notre équipe, vous piloterez des projets visant à garantir la sécurité des patients et la conformité aux réglementations internationales de l’industrie pharmaceutique.

À ce poste, vous superviserez des aspects essentiels de la pharmacovigilance, en collaboration avec des équipes pluridisciplinaires, afin de fournir des résultats de haute qualité et de préserver l’intégrité de nos recherches cliniques.

Vos missions :

About the Job

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 contribute to a dynamic, ambitious team. You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.

Main Responsibilities

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 

We are seeking a Senior Safety Officer with a primary focus on the compilation, authoring, and review of aggregate periodic safety reports, including PSURs/PBRERs, DSURs, and ACOs. The role leads the coordination and development of high-quality safety reports including clinical safety evaluations, cumulative safety analyses, and benefit–risk assessments in line with global regulatory requirements. In addition to aggregate reporting and related medical writing activity, the position may support additional pharmacovigilance activities such as risk management, regulatory submissions, compliance oversight, SOPs, training, audits, and CAPA implementation.

Requirements

·       Education: Degree in Life Sciences (Pharmacy, Medicine, Biology, Chemistry); advanced degree (MSc, PhD) is a plus

·       Languages: Fluent in English; French proficiency preferred

About the Job

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 lead the development of safety periodic reports within our dynamic and ambitious Safety team. You will contribute to high-quality pharmacovigilance services while ensuring compliance with industry regulations and standards in a stimulating professional environment.

Main Responsibilities:

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 Bulgaria 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

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 contribute to a dynamic, ambitious team in Pharmacovigilance. You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.

Main Responsibilities:

• Supervise pharmacovigilance case management outsourced to assigned platform(s)
• Respond to case-related emails and inquiries from external service providers
• Monitor case processing timelines and investigate any delays in reporting or transmission
• Participate in weekly quality control of data entry, MedDRA coding, and narrative writing
• Support the review and validation of clinical study case narratives for inclusion in study reports
• Contribute to the reconciliation of PV cases with business partners per Safety Data Exchange Agreements (SDEAs)
• Oversee reconciliation of cases with clinical databases managed by outsourced providers
• Collaborate closely with cross-functional and global teams to ensure compliance and data integrity

Requirements

Why Join Us?

At Excelya, we are committed to excellence in healthcare, and we invite you to be part of our dedicated team where your expertise can make a significant impact.

As a young, ambitious health company with over 900 talented professionals, we strive to be Europe's leading mid-size CRO, delivering the best employee experience. Our integrated service model enables you to engage in diverse projects, working alongside industry experts to enhance scientific knowledge and improve the patient journey.

Main activities :

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

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 contribute to a dynamic, ambitious team in PV&Safety Team[GS1] . As the Local Responsible Person for Pharmacovigilance (LRPV) in APAC region, you will play a pivotal role in ensuring compliance with local regulations, maintaining robust safety processes, and collaborating with both internal and external stakeholders to safeguard patient well-being.

Main Responsibilities:

As Local Responsible Person for Pharmacovigilance, you will:

Act as Local PV Contact

• Serve as the key contact person for local competent authorities on pharmacovigilance matters.
• Ensure full compliance with territory-specific regulatory requirements.
• Maintain oversight of product safety profiles and any emerging safety concerns.

ICSR Management