Pharmacovigilance Specialist
hace 6 días
- 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.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more
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