PVO Case Management
Handles all matters regarding AE/PTC handling in the PV team relating (but not limited) to:
- Responsible for data entry from all reporting sources in the Local Affiliate Module (LAM) of the Global Safety database (Argus) where applicable, as well as perform quality control (QC) of Individual Case Safety Reports (ICSRs), entered in LAM in accordance with PV LAM QC process.
- Liaises with the Local Quality Representative (LQR) in relation to AE reports associated with Product Technical Complaint (PTC) and aligns on actions.
- Responsible for case receipt and transfer to Argus where applicable. Identifies cases where missing or unclear information is provided and performs clarification as needed with reporter.
- Performs follow-up activities of ICSRs in a timely manner.
- Responsible for reconciliation of cases with internal functions and external partners.
- Performs the submission of the ICSRs to HA in accordance with the national regulations.
PVO Process Management
Executes a high-quality oversight of local PV process and compliance management by:
- Monitoring of local PV regulation and QSD management and maintenance of the local PSMF (Pharmacovigilance System Master File). <<please remove if not applicable to your country>>.
- Assists with local PV CAPA management activities. The PVO is also expected to overview PV quality of various programs and projects initiated by internal stakeholders.
- Contributes to audits, inspections and contract management.
- Is involved in the preparation of the PV training given to the local organization (schedule, training material, organization). When indicated by the PVCH, the PVO can completely take over the PV training.
- Conducts the local literature search for AEs as well as the routine testing of PV systems.
PVO Safety Management
Supports handling of local safety topics and issues and contributes to appropriate use of Bayer’s products by:
- Contributes to the handling and generation of aggregate reports and SUSAR/line listings reporting to National Competent Authority (NCA), relevant ethics committees and investigators in the country, where applicable.
- Participates in local safety issue management activities as requested by the PVCH.
- The PVO can be delegated by the PVCH to be involved in Risk Management Plan activities, which may involve developing and implementing additional local risk minimization measures, with other stakeholders, where applicable.
- The PVO supports the PVCH in the provision of safety input into clinical, medical and commercial studies and projects.
- Life science graduate (preferably health-care professional)
- Preferably has experience in pharmacovigilance activities.
- Good knowledge of medical terminology
- Detail-minded and task-oriented person
- Ability to adhere to procedures
- Ability to communicate orally and in writing in the local language and English
- Excellent administrative skills
- Good computer knowledge
- Strong sense of responsibility and conscientiousness, priority setting, organizing
- Stress resistance and ability to comply with strict deadlines