Local Specialist Safety Officer – Slovenia

Job Title: Local Specialist Safety Officer

Location: Slovenia

Type: Remote, part-time, 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 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.

The Local Specialist Safety Officer (LSSO) is handling local product safety (e.g. pharmacovigilance, medical device, cosmeto- vigilance) issues within EXCELYA PV & Safety team.

The LSSO’s responsibilities include collecting and assessing safety information and regulatory intelligence at the local 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.

Main Responsibilities:

• Follows EXCELYA and Client policies, procedures, instructions, guidance.
• Maintain required level of understanding of the regional vigilance legislation.
• Follows good documentation practices (including policies, procedures and practices for filing, storage and tracking of vigilance records).
• Ensure data privacy requirements are met, in accordance with EXCELYA/Client procedures and any applicable regional regulations he/she is trained to.
• Operates 24/7 safety phone line and is responsible for its proper function (including voice mail or diversion activation/deactivation as necessary) and for escalation of any issue.
• Collects, documents, forwards, follow-up, (responds where applicable) and reports appropriately and within agreed/required timelines, all case reports, complaints, queries and requests (including information about any issue of potential or actual media/public interest, including information about any potential or actual legal action or liabilities) that reach him/her or that he/she identifies.
• Performs local literature search/review or quality control on results, maintain local journal/conference lists.
• Maintains tracking systems (e.g. adverse event/query/complaints lists, journal lists, product lists, project lists, submission lists etc.).
• Is the contact person for local competent authorities regarding vigilance issues (or the back-up contact person)
• .Communicates to Competent Authorities of LSSO nomination and contact details.
• Has an overview at the required level of understanding of the safety profiles and any emerging safety concern for products for which he/she is a nominated (to the authority or to the Client) LSSO.
• Monitors changes in local vigilance-related legislation (including local guidelines, circulars etc.) and notifies timely external/internal stakeholders.
• Submits or assists for submission of vigilance related documents and reports, including preparation of cover letter(s) as applicable, follows up submissions and informs Clients or internal stakeholders as applicable.
• Performs review/quality control to local vigilance related documents.
• Performs translations or quality control on translations (according to own language competencies).
• Handles communication with external stakeholders (Clients, regulators, local collaborators etc.) keeping corresponding Safety Project Leader copied -or whenever this is not possible- informed.
• Performs reconciliation as applicable.
• Assists in or handles local communication of new safety information (like Direct Healthcare Professional Communication, Educational Material, Field Safety Notification).
• Assists in or handles implementation of local risk minimization measures.
• Within European Economic Area pharmacovigilance system, the LSSO reports directly or indirectly to the European Union Qualified Person responsible for Pharmacovigilance.