Senior Safety Specialist

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

📋 Description

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

• Engage in on-call responsibilities for designated projects to ensure 24-hour case intake coverage from research sites.

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

• Prepare for and participate in audits.

• Provide mentorship to junior staff members.

• Analyze regulatory and pharmacovigilance literature and information sources.

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

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

• Coordinate the implementation of routine projects, including Clinical Trials and Endpoint Assessment/Data Safety Monitoring Committees.

• Present findings at client and investigator meetings.

• Review metrics and budgetary considerations.

• Collaborate with project teams, clients, investigators, adverse-event reporters, and third-party vendors.

⛳️ Requirements

• Bachelor's degree or equivalent with relevant formal academic or vocational qualification.

• Over 5 years of prior experience contributing relevant knowledge, skills, and abilities.

• Consideration may be given for equivalency through a combination of suitable education, training, and/or directly related experience.

• Comprehensive understanding of pathophysiology and disease mechanisms.

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

• Excellent critical thinking and problem-solving abilities, with appropriate evaluation and escalation skills.

• Proficient in managing complex clinical study administration, budget tasks, and forecasting.

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

• Proficient in English with the ability to translate information into the local language when necessary.

• Computer literate with the capability to navigate multiple databases.

• Proficient in Microsoft Office Suite, including Outlook, Word, and Excel.

• Thorough understanding of global regulatory standards and compliance with procedural documents and regulations.

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

• Strong attention to detail.

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

• Ability to work effectively as part of a team.

• Occasional domestic and/or international travel may be required.

🏝️ Benefits

• Opportunities for collaboration and professional development.

• Global team environment.

• Work culture focused on scientific excellence.