Buenos Aires C.F.
Position purpose: Manager with overall accountability for medical responsibility in Cono Sur :Argentina , Uruguay , Paraguay , Chile and Bolivia , encompassing all Bayer Pharma and Consumer Health business .( R and F supervisor of Medical Director Chile and Uruguay ) Manager with overall accountability for Pharmacovigilance in Cono Sur , PH and CH business. Manager with functional responsibility on Regulatory Affairs PH Cono Sur ( F supervisor of regulatory manager) . Manager with administrative accountability for Clinical Operations PH in Argentina . ( A supervisor of Local Head of Clinical Operations Latinamerica ) Lead,
develop and direct the Medical Function in the organization by medical structures ensuring medical governance and compliance with
International Pharmaceutical Standards, PH Standard Operating Procedures (SOPs), IFPMA Code of Pharmaceutical Marketing Practice and other as applicable. Support the business and foster the business growth of the Cono Sur Region by developing and implementing medical and clinical processes and activities in alliance with the overall PH and CH strategy. Medical Director has the Code Compliance Officer functions in Argentina.
Major tasks and responsibilities:
: Accountable for Medical Governance within the Sub:regions organization.
: Has the duty of supervision and due diligence for all activities promoted or induced by the company that directly or indirectly involve exposure of a human being to any pharmaceutical or consumer health product of the Bayer Group. Such supervision and due diligence must be such as to enhance the benefitrisk relationship for user, product and company.
: Setting and maintaining a culture of the highest ethical standards for any medical activity that the sub:region organization is involved in.
: Is responsible together with the sub:region Divisional Head to ensure that the personnel of the local organization are adequately trained on the processes related to Drug Safety and Product Quality (handling of adverse effect reports and / or product quality complaints). This responsibility is extended to the CH business.
: Ensure that all medical personnel are familiar with and adequately trained in the basic ethical, scientific and legal and related principles governing medical and related activities within the Pharmaceutical Industry and their implications with regards to following key processes:
: Product information: : Labeling : Medical information (information on medical questions and information about products) : Drug Safety ( PH and CH business) : Clinical activities: studies / trials; registries support , etc. : Management of crisis related to products or to medical activities
: Has the duty of supervision and due diligence for studies conducted in the sub:region by any sponsoring unit within PH.
: Regarding Investigator Iniciated ResearchTrials and Collaborative Group Sponsored Trials the Sub:region Medical Director is responsible to ensure that the conduct of the study is according to the applicable regulations and terms of contract in such a way that the participating subjects / patients are not exposed to unnecessary risks.
: Ensure that all product:related material for communication or promotion is consistent with the approved label.
: Manages and implements all medical and PV activities in the sub:region by leading the appropriate functional groups to cover following functions:
Pharmacovigilance and Drug Safety, Clinical Development, Post registration studies, Medical information, Product related information comunication, Medical training, Regulatory Affairs.
: Accountable for the local budget of Medical Function responsible to align performance goals with the respective Bayer Consumer Health organisation for oneself and the department. Strategy and Implementation.
Internal: The major work interactions of the position are:
a. Global and Regional Medical Affairs, Pharmacovigilance , Clio Ops and Regulatory affairs Manag
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