Medical Affairs Manager - Pharmacovigilance

hameln pharma gmbh; Hameln; Vor Ort; EUR 60.000 - 80.000; Vollzeit

Benefits dieser Stelle

30 Tage Urlaub

Flexible Arbeitszeiten

Betriebliche Altersvorsorge

EGYM Wellpass

Mahlzeitenzuschüsse

Zusammenfassung

Ein Pharmaunternehmen in Niedersachsen sucht einen Medical Affairs/Pharmacovigilance Manager. In dieser Rolle unterstützen Sie die Arzneimittelinformation und die Sicherheitsberichterstattung. Sie arbeiten mit verschiedenen Abteilungen zusammen, um Qualität und Patienten Sicherheit zu gewährleisten. Ein abgeschlossenes Pharmaziestudium sowie Erfahrung in medizinischen Angelegenheiten sind erforderlich. Flexible Arbeitszeiten, 30 Tage Urlaub und ein modernes Arbeitsumfeld werden geboten.

Qualifikationen

• Abgeschlossenes Studium der Pharmazie.
• Relevante Erfahrung in den Bereichen Arzneimittel-/Patientensicherheit, medizinische Angelegenheiten und Pharmakovigilanz.
• Vertrautheit mit der klinischen Anwendung von Medikamenten.

Aufgaben

• Bereitstellung von Arzneimittelinformationen für hameln-Produkte.
• Unterstützung bei der Vorbereitung und Überprüfung von Sicherheitsberichten.
• Zusammenarbeit mit Qualitätsmanagement zur Beurteilung eintreffender Qualitätsmängel.

Kenntnisse

Pharmazeutisches Fachwissen

Kommunikationsfähigkeiten in Deutsch und Englisch

MS Office Kenntnisse

Dokumentenmanagement-System Erfahrungen

Ausbildung

Studium der Pharmazie

Tools

docuBridge

Jobbeschreibung

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.

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 confidently 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