Pharmacovigilance Lead/Manager (PL) - Poland
The duties associated with the role include:
- Overseeing toward the active portfolio of clinical trials where PV services are contracted (ensuring compliance with GCP and relevant country and international regulations).
- Managing of safety associates, including workload management.
- Performing EudraVigilance registration and reporting.
- Collaborating with global regulatory affairs and operations to ensure timely submission of SUSAR to authorities and investigators.
- Managing and overseeing of PV systems.
- Representing the company during subject matter conferences and industry events.
- University/college degree (life science preferred)
- Minimum of three (3) year of clinical research experience and minimum one (1) year in pharmacovigilance/safety area
- Very good knowledge of GVP, GCP, local regulatory requirements, ICH Guidelines, European Directives
- Ability to work independently and efficiently according to local regulations, SOP, ICH GCP, GVP, EU Directives
- Experience in processing safety data within Argus or another PV databases a plus
- Very good command of English language
- Computer competency — MS Office environment
- Good planning, organization and problem solving abilities
- Good communication and interpersonal skills
- Good analytical and negotiation skills