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.
Foster the safety of our products to ensure “Bayer´s license to operate” in Colombia.
Assures the correct implementation and observation of all safety related Quality System Documents (QSD) of Bayer referring to local safety activities.
Contributes to appropriate AE/PTC and device event handling aligned with country set up (i.e. LAM country/ Cluster/ Hub) related to the case receipt, clarification, follow up Submits Individual Case Safety Reports to the local Health Authorities of Colombia according to the local regulations in conjunction with PVRC-LA; provides local support to PTC and counterfeit process.
Participates in local safety issue and crisis management activities in collaboration wit...