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Alliance Manager

posted by: spj_bot

About the Job

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We are committed to fostering innovative partnerships that deliver value while transforming the clinical research landscape.

The Alliance Manager ensures that this transition happens smoothly, safely, and in line with regulatory obligations.

This role acts as a central project coordinator, working across PV, Regulatory, Legal, Supply Chain, and Business teams to secure the full transfer of safety responsibilities to the partner or acquiring company.

Main Responsibilities

1. Pharmacovigilance Transfer Coordination

  • Coordinate end‑to‑end PV responsibility transfers when a product is sold or licensed to another company.
  • Ensure safety data, regulatory obligations, and contractual PV commitments are clearly documented and handed over.
  • Prepare and manage PV documentation required for buyers or partners.
  • Support alignment between internal PV teams and external partners throughout the transition.

Job Skills

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RWE Project Manager

posted by: spj_bot

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.

Working in close collaboration with the Therapeutic Area Medical Lead, the Data Generation Strategy Lead, the Medical Data Center Statistician, Pharmacovigilance teams, and partners, the MEPS will manage assigned studies across one or more therapeutic areas, including Oncology, Hematology, Neuroscience, Immunology, and Ophthalmology.

The role requires strict adherence to applicable regulations, internal procedures, and compliance standards, ensuring high-quality study execution and data integrity.

Main Responsibilities:

Job Skills

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Clinical Scientist I&I

posted by: spj_bot

About the Job

At Excelya, we embrace our core values of Audacity, Care, and Energy to shape the future of clinical research. As a Clinical Scientist in Immunology & Inflammation (I&I), you will collaborate closely with a talented multidisciplinary team to drive the success of our clinical trials.

This position provides an opportunity to engage in innovative research and contribute to studies aimed at addressing critical medical needs. You will be integral to ensuring the smooth execution of clinical trials while maintaining the highest scientific and ethical standards.

Job Skills

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Global Safety Officer Senior

posted by: spj_bot

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.

You will be responsible for the medical assessment of sensitive pharmacovigilance files, often consisting of numerous medical documents. Expertise in neurology, obstetrics‑gynecology, or pediatrics is particularly valuable.

Your role will be to produce clear, accurate, and clinically rigorous medical summaries, supporting medico‑legal evaluations within the context of compensation requests.

Main Responsibilities:

Job Skills

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Safety Database Administrator

posted by: spj_bot

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:

Job Skills

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Chef de projet pharmacovigilance

posted by: spj_bot

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 :

Job Skills

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Clinical Monitoring Lead oncology

posted by: spj_bot

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

Job Skills

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Senior Safety Officer

posted by: spj_bot

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

Job Skills

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Safety Periodic Reports Lead

posted by: spj_bot

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:

Job Skills

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Safety Officer

posted by: spj_bot

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

Job Skills

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