Scientific and Regulatory Specialist
We are looking for a person with basic experience in scientific writing and chemical, biological, pharmaceutical or medical background. Experience in pharmaceutical writing or industry is an advantage. The new member of our team will be involved in various European procedures concerning scientific aspects of medicinal products. This position is suitable also for a fresh graduate, who wants to gain unique experience in pharmaceutical business.
The role will be responsible for the following:
- Providing assessments on the safety and efficacy of medicinal products in the preauthorization and post authorization phase, creates assessment reports, implements comments from the regulatory authority.
- Controling translations of the summary of product characteristics. Package leaflets, packaging and, where appropriate, monographs, finishing texts of SPC, PIL and packaging.
- Performing linguistic, stylistic and bibliographic correction of generated messages within the company
- Participating in sub-activities related to the provision of pharmacovigilance for a company or third parties
- Independently evaluating the documents from the pharmacovigilance department (PSUR, DSUR, RMP etc) in conjunction with the Director of Pharmacovigilance
- Performing quality control of pharmacovigilance documents
- Actively participating in the development and implementation of company Quality Management
- Being educated in the field of Pharmacovigilance, registration and clinical trials for medicinal products
- Participating in workshops or trainings outside the country
- Performing other activities as required by the guidelines of the supervisor
We offer the following conditions:
- Competitive salary with very attractive performance based bonus programs
- Personal bonus based on performance
- Contribution to lunch
- Contribution to insurance (life/pension)
- 20 days of paid holiday
- Young, motivated and international team of colleagues
- Continuous specialized training
If you feel that you have the right background combined with the right attitude, we would be delighted to receive your application with a structured CV in English at firstname.lastname@example.org.