Medical Governance & Pharmacovigilance Manager - North Africa Cluster
Minimum Level of Education: Scientific background
Minimum of 3 years experience in medical department in pharmaceutical industry, PV is mandatory
Experience in a multinational company is mandatory
- Language skills: French & English are mandatory
As Named Safety Contact for Algeria, has overall responsibility for the day to day management and operational aspects of pharmacovigilance for marketed products and products in clinical trials, including all Pharma products, Vaccines and Consumer Healthcare products. This includes ensuring compliance with all local regulations and GSK global pharmacovigilance requirements, and includes but is not limited to:
oCollection of adverse events (AEs), recording in the country register and reporting of AEs to Central Safety Departments.
oTimely reporting of AEs/SAEs to the local regulatory authority as required.
oSubmission of ICSRs/PSURs and other periodic safety updates to Regulatory Authorities, Investigators and Ethics Committees as required.
oEnsuring a out of hour system is in place for AEs reporting.
oTraining of all operating company staff in AE reporting and Coordinates necessary training for all relevant North Africa staff (Algeria, Morocco and Tunisia).
oConducting of third parties PV systems and products Due Diligences.
oEnsuring Safety Data Exchange Agreements (SDEAs) are in place with third parties with which GSK has business contracts and monitoring the SDEAs at least once a year for a potential revision need. Maintenance of SDEAs by uploading them to the SDEA database.
oMaintaining a local PV system for POLOs and updated.
oEnsuring LOC PV SOPs are in place maintained and regularly reviewed and arranges translation of the SOP into local language as required.
oEnsuring processes are in place for all sources of post marketing solicited AEs.
oInforms the North Africa staff when the North Africa PV SOPs is effective (Algeria, Morocco and Tunisia).
oProviding access to the PV SOPs to all relevant staff.
oEnsuring a monthly monitoring of local medical and scientific literature for adverse events and reporting these AEs identified in the local journals in compliance with the local regulatory and company requirements
oEnsure regular reconciliation
oEnsuring a close and timely communication with the relevant staff responsible for product complaints and medical information processes; establishing the appropriate infrastructure to make sure that the AEs derived from these processes are reported on time and that the periodic reconciliation process of product complaints and medical information enquiries with AEs are in place.
oProviding product safety support, guidance and training as necessary to the relevant personnel in compliance with the relevant policies and procedures when engaging in activities that may generate human safety information (including adverse event reports) via Patient Support Programmes (PSP), Market Research (MR) and Interactive Digital Media (IDM) activities.
oMaintaining a PV risk management planning process.
oMonitoring of local regulations with regards to pharmacovigilance.
oNotifying CSD when new Safety staff are appointed or where there is a change in contact information for safety personnel
oNotifying CSD about the local regulatory and procedural changes and providing the updated documents to be uploaded into North Africa PV Portal (Algeria, Morocco and Tunisia).
- Medical Governance:
oWorks with the Area Medical Governance and PV Director to define the North Africa (Algeria, Morocco and Tunisia) Medical Governance strategy to assess, track and mitigate Medical Governance related business risks (including risks identified in metrics, risk assessments and/or audit reports )
oImplements Africa (Algeria, Morocco and Tunisia) Medical Governance strategy to ensure compliance with all relevant global GSK and local regulatory requirements, including conduct of relevant monitoring activities and to mitigate business risk related to these activities.
oProvides support to all relevant Africa (Algeria, Morocco and Tunisia) personnel in understanding their accountabilities to fulfil all GSK and local requirements for MG and PV.
oEnsures the Africa (Algeria, Morocco and Tunisia) is prepared for Medical Department internal audits and Regulatory Agency inspections, providing support and advice as required.
oEstablishes and implements systems and processes to ensure that the North Africa (Algeria, Morocco and Tunisia) Medical Department appropriately manages business risks, and that the North Africa (Algeria, Morocco and Tunisia) management monitors the success of the Medical Governance operating model.
oKeeps Medical Governance processes up to date with the relevant changes and ensures appropriate and timely implementation in the relavant departments, providing advice to the personnel as required.
oSupports the organisation with appropriate training on Medical Governance, including and ensuring all staff receive training to keep up to date with new regulations and associated business processes.
oCommunicates proactively and regularly with the employees in the North Africa (Algeria, Morocco and Tunisia) to keep them abreast with global activities and trends, performance metrics, process activities and overall operational information that assists them in developing their country activities.
oBe the responsible person for medical information.
You may apply for this position online by selecting the Apply now button.
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