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