Overview

Work model: Hybrid (2-3 days on site, the rest remote)

Type of contract: 12 - month contract with a possibility of extension

Pay rate: Based on market demand

Our client: A global organization providing advanced data analytics, clinical research, and technology solutions for the healthcare sector. It supports pharmaceutical and medical companies in making data-driven decisions and developing innovative therapies.

Position Summary

Review, assess, and process safety data and information across service lines, received from various sources, and distribute reports/data to both internal and external third parties in accordance with applicable regulations, SOPs, and internal guidelines, under the guidance and support of senior operations team members.

Key Responsibilities

• Prioritize and complete all assigned trainings on time.
• Process safety data according to applicable regulations, guidelines, SOPs, and project requirements.
• Perform pharmacovigilance activities as per project needs, including but not limited to:
• Collecting and tracking incoming Adverse Event (AE)/endpoint information.
• Determining initial/update status of reported events.
• Entering data into the database and coding AEs and products.
• Conducting literature review activities within internal/project timelines.
• Ensure quality standards are met according to project requirements.
• Maintain productivity and delivery standards as required.
• Ensure full compliance with all project-related processes and activities.
• Read, understand, and acknowledge all required IQVIA SOPs and customer-specific SOPs.
• Complete all mandatory trainings on time and ensure documentation is properly maintained.
• Ensure your individual training plan and transcript are consistent and up to date.
• Create, maintain, and track case data as per the project plan.
• Identify any quality issues and report them to senior team members.
• Demonstrate problem-solving capabilities.
• Liaise with cross-functional team members to resolve project-related issues.
• Communicate with clients regarding daily case processing activities, as required.
• Mentor new team members when assigned by the manager.
• Attend project team meetings and provide feedback to the operations manager regarding challenges, issues, or successes.
• Perform other duties as assigned.
• Lead or support departmental initiatives.
• Ensure 100% compliance with all people management practices and processes.

Additional Responsibilities (Depending on Project Requirements)

Depending on the project, the team member may perform medical review of non-serious Adverse Events (AEs) and non-serious Adverse Drug Reactions (ADRs), which includes:

• Reviewing AE coding, medical history, concomitant medications, expectedness/listedness, causality assessment, and other medical details.
• Ensuring completeness and accuracy of data according to applicable regulations, guidelines, SOPs, project-specific and medical evaluation guidelines.
• Communicating with team leads regarding any required corrections and maintaining proper documentation of all communications.

Qualifications

• Required: Bachelor’s degree in life sciences or a related field, with up to 3 years of relevant experience (including up to 1 year of pharmacovigilance experience).
• Equivalent combinations of education, training, and experience may be considered.
• At least two, preferably three languages required. English/German or English/French preferred.
• Good knowledge of medical terminology.
• Intermediate working knowledge of safety databases and internal/client applications.
• Understanding of global, regional, and local clinical research regulatory requirements.
• Excellent attention to detail and accuracy; ability to maintain high quality standards.
• Proficient in Microsoft Office and web-based applications.
• Strong organizational and time management skills.
• Strong written and verbal communication skills.
• Self-motivated, adaptable, and flexible.
• Ability to follow guidelines, use initiative, and work independently.
• Ability to multitask, meet strict deadlines, and manage competing priorities.
• Ability to delegate tasks to less experienced team members.
• Flexibility and openness to changing process requirements.
• Willingness and ability to learn new skills across safety service lines.
• Ability to establish and maintain effective communication and working relationships with coworkers, managers, and clients.
• Team player mindset, contributing to and supporting overall team goals.
• Ensure quality of deliverables according to agreed terms.
• Demonstrate company’s core values in day-to-day work.

Working Conditions

• Frequent use of telephone and face-to-face communication requiring accurate speech perception.
• Regular sitting for extended periods.
• Occasional travel may be required.
• Flexibility to work in shifts as needed.

eTeam Workforce sp. z o.o. is an employment agency registered in a registry kept by the Marshal of the Mazowieckie Voivodeship under the number 21300