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Operations specialist 1

Oeiras
IQVIA
Anunciada dia 22 maio
Descrição

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, SOPs and internal guidelines under guidance and support of senior operation team members.Essential FunctionsPrioritize and complete the assigned trainings on time.Process safety data according to applicable regulations, guidelines, Standard Operating Procedures (SOPs), and project requirements.Perform pharmacovigilance activities per project requirement, including collecting and tracking incoming adverse events (AE) and endpoint information.Determine the initial/update status of incoming events.Perform database entry.Code AE and products, write narratives, and conduct literature‐related activities as per internal/project timelines.Ensure adherence to quality and productivity standards per project requirements.Ensure compliance with all project‐related processes and activities.Read and acknowledge all necessary IQVIA SOPs and customer SOPs as required, ensuring all required training is executed timely and documented; work toward reconciling individual training plans and transcripts.Create, maintain, and track cases as applicable to the project plan.Identify quality problems, if any, and bring them to the attention of a senior team member.Demonstrate problem‐solving capabilities.Liaise with different functional team members, e.g., project management, clinical, data management, and healthcare professionals such as investigators, medical monitors, site coordinators, and designees to address project‐related issues.May liaise with clients regarding daily case processing activities.Mentor new team members if assigned by the Manager.Attend project team meetings and provide feedback to operations manager on challenges, issues, or successes.Perform other duties as assigned.Lead/support department initiatives.Achieve 100% compliance with all people practices and processes.In addition to the above, perform medical review of non‐serious adverse events (AE) and non‐serious adverse drug reactions (ADR), including AE coding, past medical history, concomitant medications, expectedness/listedness, causality assessment, and other medical information; ensure completeness and accuracy of data according to regulations, guidelines, SOPs, and maintain documentation for all communications.QualificationsBachelor's degree in Scientific, healthcare, or allied life sciences discipline.Up to 3 years of experience or equivalent combination of experience, training, and education.Good knowledge of medical terminology.Working knowledge of applicable safety database and any other internal/client applications.Knowledge of applicable global, regional, and local clinical research regulatory requirements.Excellent attention to detail and accuracy.Ability to maintain high quality standards.Good working knowledge of Microsoft Office and web‐based applications.Strong organizational and time‐management skills.Strong verbal and written communication skills.Self‐motivated and flexible.Ability to follow instructions and guidelines, utilize initiative, and work independently.Ability to multi‐task, meet strict deadlines, manage competing priorities, and adapt to changing demands.Ability to delegate to less experienced team members.Ability to be flexible and receptive to changing process demands.Willingness and aptitude to learn new skills across safety service lines.Ability to establish and maintain effective communication and working relationships with coworkers, managers, and clients.Ability to work as a team player, contribute, and work toward achieving team goals.Ensure quality of deliverables according to agreed terms.Demonstrate IQVIA core values while performing daily tasks.Extensive use of telephone and face‐to‐face communication requiring accurate perception of speech.Regular sitting for extended periods of time.May require occasional travel.Flexibility to operate in shifts.Potential base pay range for this role, when annualized, is 102,800.00 zł – 190,900.00 zł. The actual base pay offered may vary based on a number of factors including job‐related qualifications, location, schedule, incentive plans, bonuses, and other compensation.#J-18808-Ljbffr

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