Excelya is seeking a Local Specialist Safety Officer for Bulgaria to join our Pharmacovigilance and Safety team. In this role, you will handle local product safety issues, performing pharmacovigilance, medical device, and cosmeto-vigilance activities. We are a young, ambitious health company driven by Audacity, Care, and Energy, aiming to become Europe's leading mid-size CRO with the best employee experience.
What You'll Do
- Comply with client policies, procedures, documentation standards, and regional/national vigilance legislation.
- Maintain vigilance records, tracking systems, and data privacy in line with applicable regulations.
- Collect, assess, document, and report all safety cases, complaints, queries, and legal/media-related issues within required timelines.
- Serve as the local safety contact for competent authorities, monitor regulatory changes, and update quality system documents accordingly.
- Manage submissions, reports, reconciliations, and quality control of vigilance-related documentation.
- Participate in trainings, meetings, inspections, and audits; ensure personal CV and training records remain current.
- Provide or coordinate local trainings, ensure stakeholder awareness of safety responsibilities, and support safety agreements.
- Provide input to safety data exchange agreements in the territory.
What We're Looking For
- University degree in Life Sciences or a related field, or an equivalent combination of education and experience.
- Meets local/national requirements to act as a local responsible/qualified person (or deputy) for product safety in relevant vigilance areas.
- Relevant local experience as required.
- Strong organizational and communication skills.
- Attention to detail and ability to multi-task.
- 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.
- Proficient in MS Outlook, Word, Excel, and PowerPoint.
- Fluency in English (written and spoken).
- Responsible, detail-oriented, adaptable, and a collaborative team player.
Nice to Have
- Previous work in pharmacovigilance, clinical research, or clinical trials considered an asset.
- Familiarity with safety databases is an advantage.
- Additional languages are an asset.
Technical Stack
- MS Outlook
- MS Word
- MS Excel
- MS PowerPoint
- Safety databases
Team & Environment
You will be part of the dynamic and ambitious Pharmacovigilance and Safety team.
Excelya is an equal opportunity employer.