Safety Data Specialist

Location:
Warsaw, Poland

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, Standard Operating Procedures (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.
• Writing narratives.
• 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 (e.g., project management, clinical, data management, healthcare professionals such as investigators, medical monitors, and site coordinators) 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 prefered.
• 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