Job Summary

• 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 Standard Operating Procedures (SOPs) and internal guidelines.
• 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.
• In addition to the above mentioned responsibilities, depending on the project requirement, the team member may perform medical review of non-serious adverse events (AEs) and non-serious adverse drug reactions (ADRs).

Matching Summary

Skills & Requirements

Key Requirements

• High School Diploma or equivalent
• Bachelor's degree in life sciences or related field
• up to 3 years of relevant experience
• up to 1 year of Pharmacovigilance experience
• Good knowledge of medical terminology
• Working knowledge of applicable Safety Database
• Knowledge of applicable global, regional, local clinical research regulatory requirements
• Excellent attention to detail and accuracy
• maintain high quality standards
• Good working knowledge of Microsoft Office
• Strong organizational skills and time management skills
• Strong verbal/written communication skills
• Self-motivated and flexible
• Ability to follow instructions/guidelines
• Ability to multi-task, meet strict deadlines
• Ability to delegate to less experienced team members
• Ability to be flexible and receptive to changing process demands
• Ability to work as a Team Player

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