Pharmacovigilance Officer

Job Description

Major tasks and responsibilities of position: • Assists in the maintenance of company’s compliance with respect to laws, regulations and guidance associated with the licensure of Bayer medicinal products with respect to patient safety • Assures the correct implementation and observation of all safety related Standard Operating Procedures (SOPs), Working Procedures (WPs) and Operational Manuals (OMs) of BSP referring to local safety activities • Collects, reviews, processes and distributes the adverse event information regarding the Bayer products in all therapeutic areas; Submits the individual case safety reports to the local Health Authorities of the Iran according to the local regulations • Participates in local safety issue and crisis management activities in collaboration with the PVCH • Contributes in local safety observation detection and review of local relevant medical literature according with the PV standard operations and procedures • Education and training within the local organization; documentation of topics addressed during the training and of participants in the training • Contributes in assuring the appropriate communication, coordination and alignment between local and Global PV organization. • Participates in overview and editing of translation of local’s health authority guidelines in collaboration with the PVCH Regulatory Authority queries and inspections • Medical Affairs and Clinical Development – e.g. regarding protocol and informed consent review and investigator sponsored studies • Legal – ensure that local legal representatives are informed about ongoing safety information in regards to potential legal issues or cases in litigation • Contract management – e.g. regarding local PV agreements • GPV Systems and Operations; GPV Risk Assessment