MEDICAL INFORMATION SPECIALIST, FRENCH & ENGLISH SPEAKER

Job Overview 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 under guidance and support of senior operation team members.
Essential Functions • The team member will have to perform medical review of non-serious adverse events (AEs) and non-serious adverse drug reactions (ADRs) which includes reviewal of AE coding, past medical history, concomitant medications, expectedness/ listedness, causality assessment and other medical information and ensure completeness and accuracy of data according to applicable regulations and guidelines, SOPs, project-specific guidelines, and medical evaluation guidelines and communicate with the team leads for any correction required in the case and maintain appropriate documentation for all communications.
• 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.
• 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.
• Liaise with different functional team members, e.
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project management, clinical, data management • 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.
• Perform other duties as assigned.
• Lead/ Support department Initiatives   Qualifications • Bachelor's degree in life sciences or related field and up to 3 years of relevant experience, inclusive of up to 1 year of Pharmacovigilance experience.
• Advanced English Level • Advanced French Level • Good knowledge of medical terminology.
• Working knowledge of applicable Safety Database and any other internal/Client applications.
• Knowledge of applicable global, regional, local clinical research regulatory requirements.
• Good working knowledge of Microsoft Office and web-based applications.
• Strong organizational skills and time management skills.
• Strong verbal/written communication skills.
• Self-motivated and flexible.
• Ability to follow instructions/guidelines, utilize initiative and work independently.
• Ability to multi-task, meet strict deadlines, manage competing priorities and changing demands.
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We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world.
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