The Senior Pharmacovigilance Officer (PVO) contributes to assure patients’ safety by complying with all PV Quality System Documents (QSDs) and local and international regulatory requirements. The main purpose of the position is to ensure that Pharmacovigilance (PV) standards are met by performing and bringing expertise in case management, PV process management as well as PV local safety management activities.

Main activities are:
Case Management:
- Handles all matters regarding AE/PTC handling in the PV team relating (but not limited) to:
- Responsible for case receipt, translation related activities and transfer to SDRA 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 and liaises with PVRC, as applicable.
- Performs the submission of the ICSRs to HA in accordance with the national regulations.
- Liaises with the Local Quality Representative (LQR) in relation to AE reports associated with Product Technical Complaint (PTC) and aligns on actions.
Process Management:
- Executes a high-quality oversight of local PV process and compliance management by:
- Monitoring of local PV regulation and QSD management
- Assisting with local PV CAPA management activities. The Senior PVO is also expected to overview PV quality of various programs and projects initiated by internal stakeholders as delegated by PVCH.
- Actively contributing to audits, inspections, and contract management.
- Being involved in the preparation of the PV training given to the local/ cluster organization (schedule, training material, organization). When indicated by the PVCH, the Senior PVO completely takes over the PV training.
- Conducting the local literature search for AEs as well as the routine testing of PV systems.
Safety Management:
- Contributing 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.
- Having an active role in local safety issue management activities (including LSMT) as requested by the PVCH.
- Actively contributing to Risk Management Plan activities, which may involve developing and implementing additional local risk minimization measures, with other stakeholders, where applicable.
- The Senior PVO supports the PVCH in the provision of safety input into clinical, medical and commercial studies and projects.
Qualifications
- Life science graduate (health-care professional)
- Experience in pharmacovigilance activities (ideally 3 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
- Strong sense of responsibility and conscientiousness, priority setting, organizing and able to multi-task effectively
What we offer:
- We offer a competitive salary package with extra-legal benefits (possibility to telework and have flexible working hours), 32 days of holiday per year, full electric company car and charge pass, hospitalization and groups insurance, lunch vouchers , eco vouchers, mobile phone (data included)
- We commit to support you to perform your assignment under the best conditions (personal coaching, job relevant support / training, 360 degree year end review, …)
- Side activities will be organized regularly, to achieve a close collaboration within our team
- We want to be innovative with our work culture so we involve our consultants, building our company structure & strategy.
- We contribute to a number of charities & support the research and / or the patients in our industry.