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 Functions
- Prioritize 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.
Qualifications
- Bachelor'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.
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