Senior Safety Specialist

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

📋 Description

• Execute and potentially supervise daily Pharmacovigilance operations within a highly regulated setting.

• Gather, monitor, assess, evaluate, research, and track safety data.

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

• Work autonomously on daily PV tasks and may participate in on-call responsibilities to guarantee 24-hour case intake coverage.

• Function in a leadership role and aid in the creation of program and departmental procedural documentation.

• Prepare for and participate in audits.

• Mentor junior staff members.

• Review regulatory and pharmacovigilance literature and information sources.

• Maintain medical knowledge of relevant therapeutic areas and disease conditions.

• Evaluate cases and peer reports for quality, consistency, and accuracy.

• Coordinate routine project execution, including Clinical Trials and Endpoint Assessment/Data Safety Monitoring Committees.

• Present at client and investigator meetings.

• Review metrics and budgetary considerations.

⛳️ Requirements

• Bachelor's degree or equivalent, along with relevant formal academic or vocational qualifications.

• Over 5 years of relevant experience.

• Equivalence may include a combination of suitable education, training, and/or directly related experience.

• Comprehensive understanding of pathophysiology and disease mechanisms.

• Strong knowledge of relevant therapeutic areas concerning adverse-event processing.

• Exceptional critical thinking and problem-solving abilities, including appropriate evaluation and escalation.

• Proficiency in complex clinical study management, budget activities, and forecasting.

• Excellent oral and written communication skills, including the ability to paraphrase effectively.

• Good command of English and the capability to translate information into the local language when necessary.

• Computer literacy with the ability to navigate multiple databases.

• Proficiency in Microsoft Office, including Outlook, Word, and Excel.

• Strong understanding of global regulatory requirements and adherence to procedural documents and regulations.

• Ability to manage and prioritize diverse tasks and meet tight deadlines with minimal supervision.

• Strong attention to detail.

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

• Capacity to work effectively within a team environment.

🏝️ Benefits

• Global team environment.

• Opportunities for collaboration and professional development.

• Chance to make a significant impact on patient safety and scientific excellence.