Local Specialist Safety Officer Bulgaria

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 growthMains Responsibilities : The position involves performing as Local Specialist Safety Officer and is handling local product safety (e. g.

pharmacovigilance, medical device, cosmeto- vigilance) issues within EXCELYA PV & Safety team. Work in several aspects of pharmacovigilance shall be expected, such as :

Comply with Client policies, procedures, documentation standards, and regional/national vigilance legislationMaintain vigilance records, tracking systems, and data privacy in line with applicable regulationsCollect, assess, document, and report all safety cases, complaints, queries, and legal/media-related issues within required timelinesServe as the local safety contact for competent authorities, monitor regulatory changes, and update quality system documents accordinglyManage submissions, reports, reconciliations, and quality control of vigilance-related documentationParticipate in trainings, meetings, inspections, and audits; ensure personal CV and training records remain currentProvide or coordinate local trainings, ensure stakeholder awareness of safety responsibilities, and support safety agreementsProvides input to safety data exchange agreements in the territory as to address the responsibilities of each party for the fulfilment of pharmRequirementsAbout YouAt Excelya, taking audacious steps is encouraged, so we're looking for individuals ready to grow with us and share our values.

Education: University degree in Life Sciences or related field, or equivalent combination of education and experience; meets local/national requirements to act as local responsible/qualified person (or deputy) for product safety in relevant vigilance areas. Experience: Relevant local experience as required; previous work in pharmacovigilance, clinical research, or clinical trials considered an asset. Skills: Strong organizational and communication skills, attention to detail, ability to multi-task, and commitment to confidentiality; capable of handling documentation and trackers; self-motivated with the ability to work both independently and as part of a team; able to deliver trainings. Technical:

Proficient in MS Outlook, Word, Excel, and PowerPoint; familiarity with safety databases is an advantage. Languages: Fluency in English (written and spoken); additional languages are an asset. Soft Skills: Responsible, detail-oriented, adaptable, and a collaborative team player. BenefitsWhy Join Us?At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare. Here's what makes us uniqueWe 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.