Senior Safety Specialist

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

📋 Description

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

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

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

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

• Operate in a leadership role and aid in the development of program and departmental procedural documentation.

• Prepare for and participate in audits.

• Mentor junior staff members.

• Review regulatory and pharmacovigilance literature and information resources.

• Maintain a solid medical understanding of relevant therapeutic areas and disease conditions.

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

• Coordinate routine project execution, encompassing Clinical Trials and Endpoint Assessment Committee/Data Safety Monitoring Committee activities.

• Present at client and investigator meetings.

• Analyze metrics and budget considerations.

⛳️ Requirements

• Bachelor’s degree or equivalent relevant formal academic/vocational qualification.

• Over 5 years of prior experience providing the necessary knowledge, skills, and abilities.

• A combination of appropriate education, training, and/or directly related experience may be considered for equivalency.

• In-depth understanding of pathophysiology and disease mechanisms.

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

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

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

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

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

• Computer literacy and proficiency in working with multiple databases.

• Skilled in Microsoft Office applications, including Outlook, Word, and Excel.

• Thorough understanding of global regulatory standards and adherence to procedural documents and regulations.

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

• Strong attention to detail.

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

• Ability to collaborate effectively within a team to achieve a common goal.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday–Friday work schedule.

• Opportunities for collaboration and professional growth within a global team.

• Mentoring opportunities.

• Involvement in a global team dedicated to scientific excellence.