15 Лис 2018
Representative office of Aurobindo Pharma Limited in Ukraine due to staff expansion is announcing competition to fill the vacancy Local Contact Person of Pharmacovigilance.
· Higher education (medical or pharmaceutical)
· 1 year + of experience in Pharmacovigilance or Regulatory Affairs areas
· English on upper-intermediate level required
· Strong time management and organization skills
· Accuracy in details
· Overview of safety variation submissions for SmPC and Patient Information Leaflet for local products during registration, re-registration and variation procedures
· Preparation all documentations of safety variations for submission to the local authority
· Submission of PSURs, RMPs, ACOs, Benefit/Risk Assessments as required for registration and re-registration procedures
· Review of locally held medical and scientific journals for ICSRs and other relevant safety information, submission literature overview to GPVD monthly.
· Implementation of local Risk Minimisation Measures as required
· Conducting regulatory activities related with pharmacovigilance activities.
· Implementation of global PV procedures at local level.
· Ensure that pharmacovigilance activities are performed and described on local level.
· Communication between local authority and Global PVD.
· Collection and follow-up of local ICSRs and forwarding to GPVD
· Submission of the expedited reports to the local regulatory authority in accordance with regulatory requirements as required
· Preparation of local monthly PV compliance reports
· Training of all local staff as required
· Archiving of local PV documents
· Review of local legislation on pharmacovigilance to enable global PV system to adhere to local regulatory requirements
· Translation of any safety documents if required
· Provision of information to support product of the PSMF for above responsibilities
Competitive salary. The official employment in accordance with the Labour Code of Ukraine. Professional development.