Operations Specialist
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Job Description
Operations Specialist reviewing and processing safety data for clinical research services. Working remotely in a bilingual environment, ensuring compliance with regulations and guidelines.
Responsibilities:
- Review, assess, and process safety data and information across service lines, received from various sources.
- Distribute reports/data to both internal and external third parties following applicable regulations, Standard Operating Procedures (SOPs), and internal guidelines under the guidance and support of senior operation team members.
- Process safety data according to applicable regulations, guidelines, SOPs, and project requirements.
- Perform pharmacovigilance activities, including collecting and tracking incoming Adverse Events (AEs) and endpoint information, determining initial/update status of incoming events, database entry, coding AEs and products, writing narratives, and literature-related activities.
- Ensure compliance with quality, productivity, and delivery standards per project requirements.
- Liaise with different functional team members and healthcare professionals to address project-related issues.
Requirements:
- Bachelor’s degree in Life sciences or a related field (mandatory)
- Fluency in English. C1 level minimum in English (will be evaluated)
- Fluency in French is a plus.
- Up to 3 years of previous clinical experience (desirable)
- 1 year of pharmacovigilance experience will be highly valued (desirable)
Benefits:
- 100% remote role
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