Your missionAt AiCuris, the role of the Pharmacovigilance Officer is of the highest importance. Bringing broad knowledge to the drug safety function, you are embedded into AiCuris project teams and support drug development related to all aspects of pharmacovigilance during discovery, drug development, regulatory review and approval. One of the long-term goals of this role is to extend the AiCuris drug safety function towards a marketing authorization holder.ResponsibilitiesResponsible for all drug safety aspects within development and future marketed new drugsOverseeing the risk-benefit profile of all drugs under developmentBeing the contact for regulatory agencies related to safety as well as the primary contact for PV inspections in EuropeTaking over EU-QPPV responsibility as well as the Graduated Plan Officer (Stufenplanbeauftragter (m/w/d)) function at AiCuris as needed in the futureImplementing and maintaining the pharmacovigilance system and establishing its system master fileEnsuring adherence to the GVP modules as defined by the European CommissionContinuous observation of the regulatory landscape and scientific literature regarding pharmacovigilanceReviewing and amending safety information within development documentsResponsible for writing and reviewing adverse event narratives and periodic reportsResponsible for standard operating procedures in pharmacovigilance, regular updates and training adherenceOverseeing service providersYour profileAcademic degree in life science, preferably in human medicineProfound medical and pharmaceutical knowledgeAt least 5 years proven work experience in managing pharmacovigilance in the pharmaceutical industry including regulatory drugs in developmentGood organizational, communication and intercultural skillsFlexible, scientific working style and willingness for continuous educationHighly motivated to contribute and work in a growing and changing organizationGood knowledge of standard and specific software (e.g., Microsoft Office and electronical pharmacovigilance software)Good English (oral and written) and German (advantageous but not a primary requirement) language skillsWhy us?Unique corporate culture:Scientific excellence, a collaborative working environment and the passion to improve the lives of patients defines our work. With us, you can work together with innovation awarded experts with the proven ability to translate science into commercial success. You can expect diversity, inspiration as well as trustful collaboration.Development:We encourage people to grow and strongly support individual development and learning opportunities.Flexibility: Embracing flexible working accommodations we enable our people to integrate business into their personal life.Benefits: Employer-funded pension comes along with an attractive benefits package. #J-18808-Ljbffr