Safety Reporting Specialist

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

📋 Description

• Receive, prepare, and submit safety reports to relevant stakeholders.

• Escalate concerns to the lead and/or line manager.

• Ensure that reports adhere to regulatory timelines and comply with country legislation.

• Generate metrics and notify managers about quality or timeline discrepancies.

• Participate in project teams and take the lead on projects of small to moderate scale.

• Provide training and support to fellow team members.

• Organize and maintain safety reporting systems and related information.

• Collaborate with departments on safety reporting tasks and the setup of client accounts.

• Engage in audits and carry out testing activities.

• Share ideas and suggestions while participating in process enhancement initiatives.

• Manage and coordinate the production of regulatory and safety reports.

• Ensure precise and timely documentation of adverse events.

• Support adherence to global pharmacovigilance standards.

⛳️ Requirements

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

• Prior experience of at least 2 years in a comparable role.

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

• Strong understanding of medical terminology.

• Excellent written and verbal communication skills.

• Proficiency in Microsoft Word and Excel.

• Solid grasp of safety database functionalities.

• Thorough knowledge of procedural documents.

• Familiarity with global safety reporting requirements, including FDA regulations and guidelines.

• Capability to manage multiple tasks while producing high-quality outcomes.

• Strong attention to detail and precision.

• Ability to handle sensitive information and data appropriately.

• Proficiency in interacting effectively with all organizational levels.

• Strong critical-thinking and problem-solving abilities.

• Capability to work in an office/laboratory and/or clinical setting.

• Ability to remain upright and/or stationary for 6–8 hours each day.

• Competence in performing repetitive hand movements and frequent mobility.

• Ability to crouch, stoop, bend, and twist.

• Capacity to lift and carry 15–20 lbs.

• Proficiency in using in-house and commercial computer software.

• Ability to communicate and comprehend spoken and written information.

• Ability to perform under pressure and manage multiple tasks simultaneously.

• Regular and consistent attendance is required.

🏝️ Benefits

• Global team environment.

• Opportunities for collaboration and professional development.

• Chance to contribute to scientific excellence and groundbreaking work.