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- 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.
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