Global Drug Safety Specialist Croatia

Are you a highly skilled and motivated individual seeking a rewarding career in pharmacovigilance? Arriello, is looking for a dynamic Global Drug Safety Specialist to join our LPPV team in Croatia. 

In this role, you'll have the opportunity to collaborate with a team of experts, report directly to the Unit Lead for LPPV, and contribute to projects that shape the future of patient safety worldwide. 

***********************THIS IS A REMOTE POSITION LOCATED IN CROATIA************************

What will be your key responsibilities:

As a Global Drug Safety Specialist, your responsibilities include:

  • Local Project Management: Oversee local literature monitoring, ICSR processing, LPPV/LSO management, monthly reporting, and compliance monitoring.
  • Safety Reporting: Manage the full spectrum of safety report processing (AEs/SAEs/SUSARs) from receipt and coding to submission. Support reconciliation with clinical databases.
  • Documentation: Assist in the development of Product documentation (SmPC, IB), and management of project-related contracts and agreements.
  • Regulatory Compliance: Stay abreast of regulatory requirements, contribute to Signal Management, and support Benefit-Risk Management activities.
  • Training and Improvement: Provide training to project teams, support process improvement within the department, and escalate technical project issues when necessary.

Key Responsibilities:

Project Excellence: Demonstrate excellence in project support, meeting deadlines, and delivering projects in accordance with client needs and contractual agreements.

Process Ownership: Act as a Process Owner for assigned Global Drug Safety processes, ensuring adherence to company standards.

Training and Collaboration: Provide training to team members, actively participate in internal and external trainings, and enhance teamwork collaboration by sharing best practices.

Continuous Improvement: Seek and incorporate client and internal feedback for continuous improvement of efficiency and work quality.

Stakeholder Management: Effectively manage relationships with stakeholders, ensuring compliance with processes and project deliverables.

CAPA Management: Ensure timely management of CAPAs related to assigned projects and tasks.

What experience should you have:

  • Bachelor’s degree or graduate in pharmaceutical sciences or related fields (advanced degree preferable).
  • Minimum of 3 years of experience in a medical or safety department.
  • Strong knowledge of Drug Safety processes, regulations, and guidelines (ICH, GVP, GCP, CIOMS, etc.).
  • Significant experience working with a safety database.
  • Fluent verbal and written English and another European Language.
  • Excellent team player with organizational and time-management skills.
  • Strong communication skills, maintaining a positive, result-oriented work environment.

What do you get in return:

  • Remote working (Use of our offices in various locations, co-sharing work space or remote options available)
  • 5 weeks holiday plus national holidays in your given location
  • 3 personal days
  • Flexible benefits, based on location
  • Home office stipend
  • Annual bonus program
  • Other employee Bonuses (spot bonuses and employee nominated bonuses)
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