Your JobProfessional leadership and provision of medical expertise to clients in the entire field of pharmacovigilance: Evaluation of the benefit-risk profile of drugs based on current medical and scientific knowledge - this includes the creation of safety update reports PSURs (Periodic Safety Update Reports), DSURs (Development Safety Update Reports), risk management plans and signal detection reportsPreparation, generation and review of clinical expert statementsIndividual Case Safety Report (ICSR) medical assessment of adverse drug reactions deriving from clinical trials, spontaneous reporting systems and the literature; decision on expedited reporting; reporting of ICSRs to the competent authoritiesMedical Evaluation of safety-related publications in the scientific literature; supporting the team members within the field of pharmaceutical scientific requests referring to the PHARMALEX literature surveillance system Vigilit®Creation and implementation of Pharmacovigilance Agreements (PVAs)Preparation and maintenance of Pharmacovigilance System Master Files (PSMFs) Leadership, management and strategic tasks: Communication and implementation of decisions of the General Management, the Head of Pharmacovigilance Germany and the Head of Global Pharmacovigilance VDC.Representation of departmental interests towards the Head of Pharmacovigilance Germany and the Head of Global Pharmacovigilance VDC.Leadership and coaching of the dedicated employees; conduct of probation period, annual employee evaluation and goal setting meetingsRepresentation of the company and the department towards clients, authorities and associations.Build, develop and maintain working relationships with clientsResponsibility for the working organization, the projects and the assignments of tasks within the departmentCollaboration in designing the division and department strategy.Maintenance of interfaces to other departments.Economic steering and observation of all projects within the pharmacovigilance area of responsibility.Operational steering of the pharmacovigilance department/area under responsibility.Definition of processes and regulations within the pharmacovigilance department/area under responsibility.Formation of the leadership culture in close cooperation with the Head of Pharmacovigilance Germany and the Head of Global Pharmacovigilance VDC.Creation of a motivational working environment.Participation in relevant executive management meetings; ensure transfer of important information from the meetings to the PHV team membersTake over responsibility for the preparation of quotations and invoices following coordination with the Head of Pharmacovigilance Germany and the Head of Global Pharmacovigilance VDC.Take over responsibility for planning, processing and feasibility of projects within the pharmacovigilance unitInform the Head of Pharmacovigilance Germany and the Head of Global Pharmacovigilance VDC regularly about systematic problems that could jeopardize an appropriate coordination of tasks and to elaborate solutions In addition, the employee performs the following tasks: Training of staff in selected areas of pharmacology as well as training in safety-relevant aspects related to the use of medicinal products. In addition, contents in the field of development, production, examination and storage of medicinal products are providedFollow-up of scientific and regulatory development especially concerning the topic pharmacovigilance and passing on relevant information to PharmaLex employees and clientsEducation and training of pharmacists or pharmaceutical trainees as well as other health care professionals ​​​​​​​Your Profile Successful completion of a master’s degree in medical, natural sciences or pharmacy, ideally also a PhD8-10 years experience and profound knowledge in the field of pharmacovigilanceExpertise; experience and knowledge regarding relevant legislative and non-legislative guidelines on pharmacovigilanceDetailed knowledge of the related SOPs (global and local)Participation in all relevant courses of instruction such as PharmaLex-internal trainings and applicable external coursesExperience in all operative tasks that are performed by the members of the pharmacovigilance departmentIdeally experience in personnel managementExperience in defining and implementation of strategies and processesFamiliarity with industry principles of pharmacovigilanceAbility to organise operational procedures and manage different tasks at the same time (e.g. effective coordination of personnel resources for time-conflicting projects)Basic economic knowledge and experience to efficiently steer the dedicated projectsGood leadership qualitiesAbility to analyse and solve problems and to develop possible solutionsAbility to motivate teams and simultaneously manage several projectsAbility to represent the company towards externalsGerman and English language fluencyResilience, willingness to work a flexible schedule and travel We offer Diverse and challenging jobOpen and appreciative corporate cultureFlexible working hours based on trustPossibility to work reduced number of hoursPossibility to work from homeContinuous development opportunities through knowledge and experience as well as training​​​​​​​