Local Specialist Safety Officer

Excelya

3d

About The Position

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.

Requirements

• Minimum of 1 year of experience in Pharmacovigilance.
• Meeting the local/national requirements for performing as local responsible/contact/qualified person in pharmacovigilance.
• Life-science graduate or relevant degree, or an equivalent combination of experience and education.
• Fluency in English and Slovenian language.

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.
• 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.

Benefits

• 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.

What This Job Offers

• Job Type: Part-time
• Career Level: Mid Level
• Education Level: Associate degree