Operations Specialist 1 (German)

The Pharmacovigilance and Case Intake Specialist/Operations Specialist 1 reviews, assesses, and processes safety data. This role involves distributing reports/data to internal and external parties, following regulations, SOPs, and guidelines with support from senior team members.

Essential Functions

• Complete assigned training on time.

• Process safety data per regulations, guidelines, SOPs, and project requirements.

• Perform pharmacovigilance activities, including:

  • Collecting and tracking Adverse Events (AEs).

  • Determining status of incoming events.

  • Database entry and coding AEs/products.

  • Writing narratives and conducting literature-related activities.

• Ensure quality and productivity standards are met.

• Comply with all project-related processes and activities.

• Read and acknowledge necessary SOPs and ensure timely training.

• Create, maintain, and track cases.

• Identify and report quality issues.

• Demonstrate problem-solving skills.

• Liaise with team members and healthcare professionals to address project issues.

• May liaise with clients on case processing activities.

• Mentor new team members if assigned.

• Attend project meetings and provide feedback.

• Perform other duties as assigned.

• Lead/support department initiatives.

• Ensure compliance with all people practices and processes.

• Perform medical review of non-serious AEs and ADRs as required.

Qualifications

• Bachelor's degree in life sciences

• Up to 1 year in pharmacovigilance and/or intake case processing experience, desirable.

• Advanced level of English

• Advanced level of German

• Excellent attention to detail and accuracy.

• Ability to delegate and adapt to changing demands.

• Willingness to learn new skills across safety service lines.

• Ability to establish effective working relationships with coworkers, managers, and clients.

100% remote role