Safety Associate

Safety Associate

Mexico City, Mexico | Home-based | R1567378

Review, assess and process Safety data and information, across service lines, received from various sources and distribute reports/data onwards to both internal and external third parties following applicable regulations SOPs and internal guidelines under guidance and support of senior operation team members.

Essential Functions

• To Prioritize and complete the assigned trainings on time.
• Process Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements.
• To perform Pharmacovigilance activities per project requirement including but not limited to, collecting and tracking incoming Adverse Events(AE)/endpoint information
• Database entry
• Coding AE and Products, writing narratives, Literature related activities as per internal/project timelines.
• Ensure to meet quality standards per project requirements.
• Ensure to meet productivity and delivery standards per project requirements.
• Creating, maintaining and tracking cases as applicable to the project plan.
• Identify quality problems, if any, and bring them to the attention of a senior team member.
• To mentor new teams members, if assigned by the Manager.
• Attend project team meetings and provide feedback to operations manager on any challenges/issues or successes.
• 100% compliance towards all people practices and processes
• Perform other duties as assigned.

Qualifications

• Bachelor's degree in Life sciences or a related field (mandatory)
• Fluency in English and Spanish (mandatory) (will be evaluated)
• 1 or 2 years of pharmacovigilance experience will be highly valued (desirable)
• Experience with Safety Databases will be highly valued (ARGUS or others) (desirable)
• Knowledge of applicable global, regional, local clinical research regulatory requirements. (desirable)
• Excellent attention to detail and accuracy.
• Good working knowledge of Microsoft Office and web-based applications.
• Strong organizational and time management skills, with the ability to multitask and manage competing priorities and deadlines.
• Strong verbal/written communication skills. Intermediate
• Self-motivated and flexible. Intermediate

Where you'll work

You'll work remotely, with the flexibility to do your best work from home. Supported by collaborative tools and a global team, you'll stay connected while enjoying the autonomy and balance that comes with a fully remote role.