Case Intake Specialist, Italian & English Speaker

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, 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.g. 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 Italian 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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