Regional RA/QA/Safety Manager

vor 2 Wochen

Düsseldorf, Deutschland Karo Healthcare Vollzeit

Karo Healthcare, a dynamic and growing company, is all about making smart choices for everyday healthcare. With a wide-ranging portfolio across seven categories including medical products, we own and sell over 100 brands in about 90 countries. Our portfolio includes such brands as E45, Pevaryl, Lamisil, Nutravita, Decubal and many others. Our core belief in empowering people to make intelligent health decisions drives our growth strategy, blending organic expansion and M&A. Since 2019, under EQT ownership, we're rapidly heading towards a €1 billion European leadership position in consumer health.

Join us at Karo Healthcare on our exciting journey. We're currently looking for a Regional RA/QA/Safety Manager for our office in Düsseldorf.

Tasks and responsibilities

Act as Scientific Affairs within the Central European team towards applicable stakeholders in the affiliate, managing  regulatory, quality and safety aspects of Karo’s growing portfolio, connecting Global Scientific Affairs, regional commercial organization and external stakeholders like DE/AT health authorities, business partners, and customers/consumers. 

 

QA

  • GDP management of regional partners (temperature excursions, deviations, qualifications)
  • Complaint Management
  • Durg shortage reporting
  • Regional point of contact for QA internal and external

 

RA/Information officer

  • DE and AT national translation and labelling
  • Monitoring and maintenance of local systems for medicinal products (“rote Liste” and agency portals)
  • Local RA intelligence DE and AT
  • Information officer (§74a AMG)
  • Support marketing regarding  claims compliance and review of materials (both print and digital)

Patient Safety

  • Local Patient/product Safety responsible DE and AT (Stufenplanbeauftragte/r § 63a AMG)
  • Collection, documentation and follow up of adverse events for medicinal products, (including literature cases) and vigilance for medical devices and cosmetics on the local markets
  • Management of Medical Information enquiries
  • Local PV intelligence
  • PV trainings as requested by Global Patient Safety
  • Reconciliation with local partners and Global Patient Safety
  • Management of regional Market Research projects to ensure PV compliance
  • Support EU QPPV upon request with local expertise and facilitate authority contact

You will be part of the Scientific Affairs Regional team with team members across Europe. The aim is to grow this team in order for Scientific Affairs to stay close to its most important stakeholder, the patient, consumer and HCPs.

Requirements

  • 5-10 Years experience from pharmaceutical industry with primary focus on safety and QA and 2-4 years experience from regulatory and commercial compliance
  • Good communication skills both in English and German
  • High integrity
  • High trust in your competence
  • Passionate about consumers and products
  • Committed to keeping high quality in fast execution
  • Challenging industry conventions to become better than our competitors in smart execution
  • Act with high confidence and trust in yourself and your colleagues
  • Connect across Karos Commercial Central Europe team and Global Scientific Affairs
  • Care about yourself, your colleagues, the quality of the products and safety of the patients

Benefits

  • Opportunity to create, grow, and encourage
  • Apart from a competitive salary pack, there are lots of growth opportunities to meet your personal ambitions
  • Flexible schedule and life work balance
  • Responsibility for exciting and challenging projects that have a direct, visible impact on our customers and the industry
  • Very positive work environment in a young, international, and motivated team
  • Start-up spirit while being a part of the large international organization with strong values

  

Karo Healthcare has a Diverse & Inclusive environment. We are looking for qualified candidates irrespective of gender, gender identity, sexual orientation, ethnicity, race, religion, national origin, disability or age.

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