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ExcelyaEX

Local Specialist Safety Officer

Excelya is an independent partner that serves Biotech, Pharma, and Medical Device organizations with a comprehensive range of full-service CRO, FSP, and Resourcing solutions.

Excelya

Employee count: 501-1000

Slovenia only

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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 freelance part-time role is an exciting opportunity to contribute to a dynamic, ambitious team in Pharmacovigilance Department. 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.

About the job:

The Local Specialist Safety Officer (LSSO) involves performing as Local Contact Person responsible for Pharmacovigilance for Slovenia and participating in local/global projects within the Pharmacovigilance (PV) and Safety department.

Main Responsibilities:

  • Collects, documents, forwards, follow-up, (where applicable) and reports appropriately and within agreed/required timelines, all case reports, complaints, queries and requests, that reach him/her or that he/she identifies.
  • Performs local literature search/review or quality control on results, maintain local journal/conference lists.
  • Acts as a local contact person for the national competent authorities regarding vigilance issues (or the back-up contact person).
  • Maintains required level of understanding of the regional/national vigilance legislation.

Beyond that, you will also be able to:

  • Participate in audits/inspections
  • Collect and assess safety information and regulatory intelligence at the local (national) level, ensuring compliance with the applicable local regulations and requirements, and acting as a point of contact for the local Regulatory Authorities with regards to PV and other product safety as applicable.

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.

Experience: Minimum of 1 year of experience in Pharmacovigilance.

Skills: Meeting the local/national requirements for performing as local responsible/contact/qualified person in pharmacovigilance.

Education: Life-science graduate or relevant degree, or an equivalent combination of experience and education.

Languages: Fluency in English and Slovenian language.

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.

Excelling with Care

At Excelya, Care lies at the heart of what we do. We provide equal opportunities for all and foster a diverse, equitable, and inclusive workplace where humility and boldness work hand in hand. Everyone has a space to feel valued, thrive, and collaborate with purpose.

Your challenges become our shared mission. Together, we transform bold ideas into reality—the Excelya way.

Apply today, become an Excelyate!

About the job

Apply before

Posted on

Job type

Contractor

Experience level

Education

Bachelor degree

Experience

1 year minimum

Experience accepted in place of education

Location requirements

Hiring timezones

Slovenia +/- 0 hours

About Excelya

Learn more about Excelya and their company culture.

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Excelya is an independent contract research organization (CRO) that provides comprehensive solutions to biotech, pharmaceutical, and medical device organizations. Founded in 2014 and headquartered in Paris, France, the company has established a significant global presence, operating in 28 countries with a team of over 900 experts. Excelya is dedicated to supporting its clients in delivering life-changing therapies by offering a wide range of services, including full-service CRO, Functional Service Provider (FSP), and resourcing solutions. The company's approach is guided by its core values of Energy, Care, and Audacity, which are embedded in its operational philosophy. Excelya emphasizes a collaborative 'one-team' approach, ensuring that shared success is achieved through close cooperation at every stage of a project, from regulatory affairs and clinical operations to quality assurance and strategic development. This integrated model allows for the creation of bespoke and robust trial solutions across a broad spectrum of therapeutic areas.

Excelya's operational excellence is built on a foundation of understanding client needs and a commitment to efficiency and rigorous operational, scientific, and regulatory standards. The company offers a unique, end-to-end model that provides comprehensive expertise both locally and internationally. Its services cover the full spectrum of clinical development, from Phase I trials to post-marketing studies, including biometrics, data science, regulatory affairs, pharmacovigilance, medical writing, and quality assurance. By offering flexible support tailored to the specific priorities of each client, Excelya enables them to focus on their core objectives. The company prides itself on its entrepreneurial spirit and its ability to provide customized solutions that match the scope and specificity of diverse research projects. This commitment to excellence and a people-centric culture aims to foster an environment where employees are encouraged to contribute their natural talents and personal involvement to advance healthcare collaboratively.

Tech stack

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Employee benefits

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Flexible working hours

Télétravail possible (Remote work possible)

Learning and development budget

Team members who launch a YEP become involved in growing the company intellectually, personally and operationally.

Your Exalting Projects (YEPs)

At Excelya, everyone has the opportunity of initiating a YEP (Your Exalting Project) – a project enabling other Excelyates to be involved in an initiative driving a particular field of expertise, whether it be scientific, technical or personal.

View Excelya's employee benefits
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Excelya

Company size

501-1000 employees

Founded in

2014

Chief executive officer

François Moisson, Frédéric Paqueville

Employees live in

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