Lead/manage the product safety surveillance for the operating unit (OPU) of North French West Africa and dependent countries (if applicable) by establishing and maintaining a local pharmacovigilance system which fulfills compliance with internal procedures and external requirements.
• Ensure communication to the Regional PV Head of any relevant change in relation to the product portfolio, licensing activities, clinical trial and post marketing activities, local processes, local PV regulation, audits and inspections activities, Health Authorities requests.
• Develop and maintain a local internal cross functional and an external network to facilitate the collection and distribution of safety information at a local level.
• Ensure that safety data collection from any source and safety reporting to concerned stakeholders is performed in compliance with internal procedures and according to current international regulation.
• Ensure adequate safety training of all concerned Boehringer-Ingelheim staff or staff working on behalf of Boehringer-Ingelheim in the OPU and dependent countries.
• Perform signal detection and safety surveillance for non-international products as needed including review safety sections of local labelling as required
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