Entdecken Sie eine Karriere mit tieferem Sinn

• Fixed-term role, for 6 months
• Full-time position, Monday to Friday
• Work modality: Home-based
• May require working on ARG national holidays

Job Overview
Review, assess and process Safety data and information (adverse event reports), 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
• determining initial/update status of incoming events
• 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.
• To ensure compliance to all project related processes and activities.
• 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 demonstrate problem solving capabilities.
• 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 required; students will be considered as well

• English advanced, mandatory

• Portuguese advanced, desirable
• 1-1.5 years of relevant work experience, ideally in health care or clinical research environment
• Working knowledge of applicable Safety Database, desirable
• Knowledge of applicable global, regional, local clinical research regulatory requirements. Beginner
• Good working knowledge of Microsoft Office and web-based applications
• Strong organizational skills and time management skills.