Medical Affairs Manager - Pharmacovigilance

Job description

Your mission As Medical Affairs/Pharmacovigilance Manager, you will be an important member of the team and will work with colleagues in other regions and external service providers. As Medical Affairs Manager, you will provide medical professionals with drug information for hameln products in response to medical/pharmaceutical enquiries from Germany/Austria. You will support the preparation and review of aggregate safety reports (PSURs, PBRERs) together with colleagues from the Medical Affairs team. You will work with colleagues from the Regulatory Affairs and Licensing/Product Development departments and support them with your pharmaceutical/medical expertise in the context of life cycle management, new approvals and licensing/development projects. In the area of pharmacovigilance, you will support the QPPV_EU/step plan officer in fulfilling their nationally/EU-wide statutory duties, such as processing/tracking reports on adverse drug reactions, risk minimisation measures and communicating with authorities on reportable measures such as recalls, suspected cases of counterfeit medicines or unusual distribution restrictions on a product. You will work closely with Quality Management, in particular in assessing incoming quality defects with regard to their relevance for drug safety. You will support Sales/Marketing in pharmaceutical/medical issues and in reviewing supporting materials for medical/pharmaceutical correctness/accuracy. The position offers the opportunity to qualify as an EU QPPV/Stufenplanbeauftragter (AMG §63a) as part of a structured succession plan. Your profile You have successfully completed a degree in pharmacy and have relevant experience in the areas of drug/patient safety, medical affairs and pharmacovigilance. You have a clear understanding of the clinical use of medicines, initial experience in the field of injectable medicines is an advantage, and you have a basic knowledge of current and developing legislation relevant to pharmaceutical law and pharmacovigilance. You are confident in using MS Office applications and have initial experience with document management systems (e.g. docuBridge). You are solution-oriented, highly committed and responsible. You are characterised by a structured, organised, very precise and conscientious way of working. You have an independent yet team-oriented working style and proactive thinking skills with a hands-on mentality. You communicate fluently in German and English and have the ability to work in an intercultural team. Why us? Comprehensive, industry-specific onboarding and independent work in your field of reaponsibility A good work-life balance thanks to flexible working hours and the option of mobile working 30 days' vacation and time off in special life situations Fair, attractive remuneration as well as a company pension allowance and capital-forming benefits Individual training opportunities and support for professional and personal development An attractive, modern working environment with ergonomic workstations and the option to lease a job bike EGYM Wellpass for a wide range of sports and wellness activities Discounts at numerous shops and brands through our corporate benefits Bistro offering hot meals and meal subsidies Company celebrations, such as family summer parties and annual kick-off events