Our partner has a strong position in the local pharmaceutical market and focuses on areas of significant unmet medical need and places where the company has the expertise to make a difference.
Pharmacovigilance Team Leader
- Fully proficient in all functions and responsibilities of a PV specialist.
- Ensures collection, reporting and handling of safety information associated with the products is performed according to global company and local regulatory requirements within the assigned PV hub coverage areas.
- Support and act as a deputy PV Hub Manager as needed in defined areas of responsibility, which may fluctuate according to business need.
- Manages daily workload of hub unit within the department with limited line management responsibilities
- Collaborates with Local Safety Responsibles (LSR), vendors and other departments in the area of Drug Safety/Pharmacovigilance, acts as a primary contact for information regarding assigned tasks and projects.
- Liaise with PV Hub manager with regard to resources, timelines and issues with quality, reorganizes daily workload based on priority, proactively communicates to management new issues, offers solutions and reports availability to take on new assignments.
- Trains new staff and mentors less experienced members of the team
- Acts as the primary resource for other PV specialists with regards to answering questions, sharing knowledge and assisting in resolving problems, provide technical support.
- Ensure readiness for Audits & Inspections as well as effective CAPA development & management relating to hub operational activities.
- Maintains understanding of SOPs, Work Instructions (WIs), global PV regulations, GCPs and ICH guidelines.
- University degree in Lifescience with 3-4 years of experience in the pharma industry
- Good knowledge of Windows OS, Microsoft Office applications
- At least 2 years of PV Case Processing experience ARISg/ARGUS/Oracle
- Excellent spoken and written English
- Experience working in a multinational environment
- Prior People Management experience
- Insight into the healthcare market of Hungary
- Solid experience, long-term job opportunity
- Professional training opportunities abroad
- Opportunity for continuous professional development, great carrier opportunities
- Practice in the methodology of one of the most recent individualized therapy
- Agile work, flexible working hours
- Home Office
- Competitive salary and benefit package