Local Specialist Safety Officer - Slovenia

Excelya is one of the leading CROs in Europe, founded in 2014 and headquartered in Paris. Our global team is composed of 900+ experts who understand the critical needs of clients and provide trial solutions across a broad spectrum of therapeutic areas.

We take an one-team approach to work: our shared success is the result of collaboration at every stage of a project, from regulatory affairs and clinical operations to quality assurance and strategic development.

Excelya’s vision is to achieve new advances in the field of healthcare and expertise in research development. Our goal is to help our clients deliver life-changing therapies collaboratively, so we can transform tomorrow together and to become the clinical research leader in Europe.

For our team members, excelling with care means benefitting from a stimulating professional environment that encourages personal, intellectual, and operational participation so that together we can be the best in our field. We commit to giving each Excelyate the means to express their natural talents, develop their full potential and invest their unique selves in our unique projects.

Exceya is looking to collaborate with a Freelancer for a part-time role of Local Specialist Safety Officer (LSSO) based in Slovenia. Excellent knowledge of the English and local language are required for this role..

The role:

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 (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.

LSSO Responsibilities/Tasks:

Follows EXCELYA and Client policies, procedures, instructions, guidance.
Maintain required level of understanding of the regional/national 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 and national 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.

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Education and Experience

Life science graduate or relevant degree, or an equivalent combination of experience and education.
Meeting the local/national requirements for performing as local responsible/contact/qualified person (or back-up/deputy) for product’s safety (pharmacovigilance or medical device vigilance or cosmetovigilance or as applicable relevant to product’s safety) vigilance.
LSSO responsibilities are assumed in territories where qualified.
Relative experience as pharmacovigilance officer or clinical research associate or clinical trial assistant is an asset.
MS Outlook, Word, Excel, Power Point literate.
Good organization and communication skills, sense of responsibility and confidentiality, ability in handling documents/trackers, attention to detail, ability to multi-task, team player, self-motivated and able to work both independently and within teams, ability to perform as trainer.
Fluency in English and in Slovenian.