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 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

Job Title: Senior Medical Monitor

Location: EU/Non EU

Type: Remote, Freelance

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 in Medical Affairs. 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 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

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

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.

As a Mission Safety Member, you will be entrusted with specific responsibilities for product safety management (in pharmacovigilance) on behalf of Excelya clients.

This role offers the opportunity to contribute to meaningful projects, ensuring compliance and patient safety across diverse regulatory environments.

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 contribute to a dynamic, ambitious team in Excelya Pharmacovigilance and Safety department. You will play a critical role in ensuring patient safety and driving excellence in pharmacovigilance, while enjoying a dynamic professional environment that fosters learning, collaboration, and career growth.

The Safety Project Leader is the project manager of the PV & Safety team, responsible for the implementation/provision of the activities/services described within a project/service agreement.

Safety Project Leaders are assuming full ownership of their assigned projects, which means they are fully responsible of regular contact with client and where applicable of budget (including budget forecast), invoicing, all legal issues (renewals, closures, extensions, scope etc.), quality and efficiency as well as audit readiness.

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 Global Safety. 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: