Senior Safety Specialist, FSP

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

📋 Description

• Execute daily pharmacovigilance responsibilities.

• Engage in on-call duties for designated projects to guarantee 24-hour case intake coverage from investigative sites.

• Analyze regulatory and pharmacovigilance publications along with various information sources.

• Sustain a medical understanding of relevant therapeutic areas and disease states.

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

• Create and manage regulatory safety reports.

• Support routine project implementation and coordination, which includes Clinical Trials and Endpoint Assessment Committee/Data Safety Monitoring Committee activities.

• Deliver presentations at client and investigator meetings.

• Review metrics and budget considerations.

• Provide mentorship to less experienced staff members.

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

• Conduct data entry, coding, adverse event assessment, case review, follow-up, report tracking, and regulatory reporting.

• Collaborate with project team members, client contacts, investigators, adverse event reporters, and third-party vendors.

• Assist with departmental and project-specific procedures and processes.

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

⛳️ Requirements

• Bachelor's degree in a life science discipline.

• Over 2 years of experience demonstrating relevant knowledge, skills, and abilities.

• Equivalency may be accepted through a combination of suitable education, training, and/or directly related experience.

• General recognition of pathophysiology and disease processes.

• Comprehensive knowledge of relevant therapeutic areas for adverse event processing.

• Excellent critical thinking and problem-solving capabilities.

• Strong verbal and written communication skills, including the ability to paraphrase effectively.

• Proficient in English and capable of translating information into the local language when necessary.

• Computer literate with the ability to navigate multiple databases.

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

• Familiarity with procedural documents and regulations.

• Capability to manage and prioritize diverse tasks while meeting strict deadlines with minimal supervision.

• Exceptional attention to detail.

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

• Competence in working effectively within a team environment.

🏝️ Benefits

• Global team environment.

• Opportunities for collaboration and development.

• Chance to contribute to patient safety and scientific excellence.