- A SPVM is responsible for 3 areas : SPVM 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).
- Assists with local PV CAPA management activities. The SPVM 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 SPVM can completely take over the PV training. SPVM 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 to National Competent Authority (NCA) in the country, where applicable.
- Participates in local safety issue management activities as requested by the PVCH.
- The SPVM 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 SPVM supports the PVCH in the provision of safety input into clinical, medical and commercial studies and projects.
- Contributes to appropriate AE/PTC and device event handling aligned with country set up (i.e. SCP, QA); provides local support to PTC and counterfeit process. People Management
- Lead the PV group aiming at achieving high efficiency and productivity by coaching, motivating and developing its members.
- Life science graduate (preferably health-care professional)
- Experience in pharmacovigilance activities (ideally 5 or more years)
- 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
- Strongsense of responsibility and conscientiousness, priority setting, organizing
- Stress resistance and ability to comply with strict deadlines
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