We are growing, grow with us!
Are you looking for a dynamic company with daily new challenges and opportunities?
Then, Pharmalex is your career opportunity. Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance.
Director, EU QPPV
- 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 reports
- Preparation, generation and review of clinical expert statements
- Individual 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 authorities
- Medical 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)
- 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 meetings
- Representation of the company and the department towards clients, authorities and associations.
- Build, develop and maintain working relationships with clients
- Responsibility for the working organization, the projects and the assignments of tasks within the department
- Collaboration 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 members
- Take 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 unit
- Inform 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
- 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 provided
- Follow-up of scientific and regulatory development especially concerning the topic pharmacovigilance and passing on relevant information to PharmaLex employees and clients
- Education and training of pharmacists or pharmaceutical trainees as well as other health care professionals
- Successful completion of a master’s degree in medical, natural sciences or pharmacy, ideally also a PhD
- 8-10 years experience and profound knowledge in the field of pharmacovigilance
- Expertise; experience and knowledge regarding relevant legislative and non-legislative guidelines on pharmacovigilance
- Detailed knowledge of the related SOPs (global and local)
- Participation in all relevant courses of instruction such as PharmaLex-internal trainings and applicable external courses
- Experience in all operative tasks that are performed by the members of the pharmacovigilance department
- Ideally experience in personnel management
- Experience in defining and implementation of strategies and processes
- Familiarity with industry principles of pharmacovigilance
- Ability 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 projects
- Good leadership qualities
- Ability to analyse and solve problems and to develop possible solutions
- Ability to motivate teams and simultaneously manage several projects
- Ability to represent the company towards externals
- German and English language fluency
- Resilience, willingness to work a flexible schedule and travel
- Diverse and challenging job
- Open and appreciative corporate culture
- Flexible working hours based on trust
- Possibility to work reduced number of hours
- Possibility to work from home
- Continuous development opportunities through knowledge and experience as well as training
If you are interested in joining our Pharmalex team taking over this challenging job opportunity in our future-oriented company, we are looking forward to receive your application documents stating your earliest possible starting date, any visa requirements and salary expectations on-line.
Agencies only by prior agreement for the specific job opportunity.