Pharmacovigilance Country Head Deputy (W/M)

<p align="justify"> </p> <p align="justify"><span><span><b>Pharmacovigilance Country Head Deputy (W/M)</b></span> </span></p>           <p><span><span><span><span><span><span>The Pharmacovigilance Country Head Deputy (PVCH Deputy) supports the Pharmacovigilance Country Head (PVCH). The PVCH deputy is involved in directing, managing and improving the Pharmacovigilance (PV) activities according to the French legislation and as devolved from the global Pharmacovigilance organization. He/ She provides medical safety governance to protect patients, products and the Bayer Group with special focus on the French public health needs. He/ She Assures compliance with national and relevant international safety regulations.</span></span></span></span></span></span></p> <p> </p> <p><span><span><span><span><span><span>As PVCH Deputy, the post holder supports the PVCH and replaces him/her during his/her absence. The post holder is a nominated substitute with the French HA as Correspondent for pharmacovigilance, materiovigilance, reactovigilance &amp; cosmetovigilance. In the absence of the PVCH, the post holder has the lead on PV &amp; materiovigilance &amp; reactovigilance matters.</span></span></span></span></span></span></p> <p> </p> <p><span><span><span><b><span><span><span><span>Main responsibilities </span></span></span></span></b></span></span></span></p> <p> </p> <ul> <li><span><span><span><span><span><span><span>Assists in the maintenance of company’s compliance with respect to laws, regulations and guidance associated with the licensure of Bayer products with respect to patient safety.</span></span></span></span></span></span></span></li> <li><span><span><span><span><span><span><span>Assures the correct implementation and observation of all safety related Quality System Documents (QSD) of Bayer referring to local safety activities.</span></span></span></span></span></span></span></li> <li><span><span><span><span><span><span><span>Contributes to appropriate AEs and device event handling aligned with country set up (i.e. country/ Cluster/ Hub); case receipt, clarification, follow up and reconciliation of AEs and incident reports regarding Bayer products in all therapeutic areas. </span></span></span></span></span></span></span></li> <li><span><span><span><span><span><span><span>Participates in local safety issue and crisis management activities in collaboration with the PVCH.</span></span></span></span></span></span></span></li> <li><span><span><span><span><span><span><span>Contributes in local safety observation detection and review of local relevant medical literature according with the PV standard operations and procedures. </span></span></span></span></span></span></span></li> <li><span><span><span><span><span><span><span>Education and training within the local organization; documentation of topics addressed during the training and of participants in the training.</span></span></span></span></span></span></span></li> <li><span><span><span><span><span><span><span>Provides local support to local Product Technical Complaints and counterfeit process.</span></span></span></span></span></span></span></li> <li><span><span><span><span><span><span><span>Contributes in assuring the appropriate communication, coordination and alignment between local and Global PV organization.</span></span></span></span></span></span></span></li> <li><span><span><span><span><span><span><span>Provides PV expertise to cross functional teams relating to PV/MV aspects relevant to interventional clinical trials, observational studies and investigator-initiated research. This includes providing PV training to these teams, CROs and investigators etc.</span></span></span></span></span></span></span></li> <li><span><span><span><span><span><span><span>Works with the PV Regional Center (PVRC) and maintains oversight on appropriate execution of delegated tasks, as aligned with PVCH.</span></span></span></span></span></span></span></li> <li><span><span><span><span><span><span><span>Performs regular review and analysis of local regulatory context.</span></span></span></span></span></span></span></li> <li><span><span><span><span><span><span><span>Reviews the PV components of all domestic study protocols and informed consents and ensures that these parts are compliant with the PV standards and the protocol template</span></span></span></span></span></span></span></li> <li><span><span><span><span><span><span><span>Reviews all local patient support programs and other undertakings of the local organization with potential consequences on PV obligations (e.g., Digital Activities, Active-Online-Listening programs) to ensure Pharmacovigilance principles are applied in all interactions with patients. </span></span></span></span></span></span></span></li> <li><span><span><span><span><span><span><span>As delegated by the PVCH, assures the collection, review, processing, and distribution of adverse event information on a country level regarding the Bayer pr