Global Drug Safety Specialist (SDM)
***Location: Romania Remote***
Reporting directly to the Unit Lead for Safety Data Management, the Global Drug Safety Specialist plays a vital role in supporting case management activities and providing technical assistance across various units within the Pharmacovigilance (PV) department. The successful candidate will execute project-related tasks with precision, delegate effectively, and maintain a high standard of service quality.
What will be your key responsibilities:
Role Description:
- Execute project tasks specific to the unit, including but not limited to Global Individual Case Safety Report (ICSR) processing, Global Literature monitoring, Medicinal Product Management (XEVMPD), and Product documentation (SmPC, IB).
- Act as a Safety Data Coordinator for assigned projects, overseeing, coordinating, and delegating activities within the project team.
- Manage project-related PV contracts and escalate technical project issues as necessary.
- Support the improvement of processes within the assigned unit, ensuring smooth project execution and interdepartmental coordination.
- Provide administrative support to the department, including document management, project tracking, and communication with internal and external stakeholders.
Key Responsibilities:
- Work on projects and tasks assigned by management, ensuring excellence in project support and meeting deadlines.
- Act as a Process owner for assigned PV processes and provide training to team members as needed.
- Build effective working relationships with stakeholders and ensure compliance with processes and project deliverables.
- Participate in audits, inspections, and company marketing activities as required.
- Organize and maintain documents according to the company's document management system.
What experience should you have:
- Bachelor’s degree or graduate in pharmaceutical sciences or related fields (medicine, pharmacy, life sciences) – advanced degree (e.g., masters) preferable or sufficient relevant experience
- Minimum of 3 years of experience working in a medical or safety department with robust knowledge of medical terminology or sufficient experience as assessed by the Head of Function
- Sound knowledge of Drug Safety processes, directives, regulations and guidelines (ICH, GVP, GCP, CIOMS, etc.,)
- Significant experience working with a safety database
- Fluent verbal and written English
- Excellent team player
- Organizational and time-management skills, able to prioritize work and adhere to deadlines
- Excellent communication skills
- Maintains a positive, result oriented work environment
What do you get in return:
- Competitive salary and comprehensive benefits package
- Opportunities for professional development and growth
- Collaborative and innovative work environment
- Involvement in high-impact projects with global reach
- Supportive team and leadership committed to your success
- 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
