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)
