Safety Specialist

This is a fully remote position, open to applicants in Bulgaria.

📋 Description

• Execute daily pharmacovigilance tasks

• Analyze regulatory and pharmacovigilance publications along with relevant information sources

• Uphold a medical understanding of pertinent therapeutic areas and disease conditions

• Evaluate cases for quality, consistency, and precision, including peer-reviewed reports

• Compile and sustain regulatory safety reports

• Organize and execute data entry, coding, adverse-event evaluations, case reviews, follow-ups, report tracking, and regulatory submissions

• Support routine project implementation and coordination for clinical trials and safety committees

• Deliver presentations at client and investigator meetings

• Assess metrics and budgetary considerations

• Mentor junior staff members

• Collaborate with project team members, client representatives, investigators, adverse-event reporters, and external vendors

• Assist in the development of departmental and project-specific procedures and processes

• Prepare for and participate in audits, kick-off meetings, and investigator meetings

⛳️ Requirements

• Bachelor's degree or an equivalent and relevant formal academic/vocational qualification

• Over 2 years of relevant prior experience

• Fundamental understanding of pathophysiology and disease mechanisms

• In-depth knowledge of relevant therapeutic areas for adverse-event management

• Strong analytical and problem-solving abilities

• Proficient oral and written communication skills, including paraphrasing capability

• Good command of English with the ability to translate information into the local language when necessary

• Computer literacy and proficiency in navigating multiple databases

• Prior experience with Microsoft Office applications, including Outlook, Word, and Excel

• Familiarity with procedural documents and regulatory standards

• Capacity to manage and prioritize diverse tasks and adhere to tight deadlines with minimal supervision

• Excellent attention to detail

• Ability to maintain a positive and professional attitude in challenging situations

• Capacity to work effectively within a team environment

• Equivalent experience through a combination of relevant education, training, and/or directly related experience may fulfill role requirements

🏝️ Benefits

• Global team atmosphere

• Opportunities for collaboration and professional development

• Workplace focused on scientific excellence