Operations Specialist 1

Berlin, Germany | Full time | Home-based | R1550314

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 Standard Operating Procedures (SOPs) and internal guidelines under guidance and support of senior operation team members.

Key responsibilities

• Provide comprehensive safety services across the lifecycle of pharmaceutical compounds and medical devices, from first in human clinical trials through post-approval, marketed product, and regulatory safety requirements. Collect, track, and report adverse events or clinical outcomes; analyse and report aggregate safety data; perform safety surveillance; and perform benefit-risk evaluation and planning.
• Provide data gathering, entry, and reporting services on behalf of contracted customers, including both clinical trial and marketed product safety activities. Triage, track, and process safety data; assess safety data for reportability to the client safety department or relevant regulatory bodies; maintain communication (phone, fax, email) with investigative sites or marketed product reporters to obtain accurate data regarding safety events; and contribute to lifecycle safety deliverables.
• In addition to the above mentioned responsibilities, depending on the project requirement, the team member may 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/ listedness, 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.

Responsibilities

• To Prioritize and complete the assigned trainings on time
• Process safety data in compliance with applicable regulations, SOPs, and project requirements.
• Perform core case processing activities, including case creation, data entry, coding, and narrative writing within defined timelines.
• Determine case status (initial/follow-up) and maintain accurate case lifecycle tracking.
• Ensure high-quality, consistent, and timely delivery aligned with project standards and productivity targets.
• Maintain compliance with internal and client procedures, including SOP acknowledgment and adherence.
• Identify and escalate quality issues or discrepancies to senior team members.
• Collaborate with cross-functional teams (e.g., clinical, data management, project teams) to resolve case-related queries.
• Communicate, as needed, with clients or stakeholders on routine case processing matters.
• Participate in team meetings and provide updates on progress, challenges, and improvements.
• Support onboarding and mentoring of new team members when assigned.
• Contribute to departmental initiatives and continuous improvement activities.
• Demonstrate problem-solving skills in day-to-day activities.
• Ensure full compliance with organizational policies and people practices.

Qualifications

• Bachelor’s Degree in Life Sciences/healthcare (or equivalent experience + up to 3 years)
• Solid understanding of medical terminology
• Working knowledge of safety databases and relevant internal/client systems
• Familiarity with global, regional, and local clinical research regulations
• Strong attention to detail with a focus on quality standards
• Proficient in Microsoft Office and web-based tools
• Effective organisation, time management, and prioritisation skills
• Strong written and verbal communication skills
• Self-motivated, flexible, and able to adapt to change
• Ability to work independently, follow guidelines, and use