Global Patient Safety Compliance Specialist

1 month ago

Stockholm, Stockholm, Sweden Karo Healthcare Full time
Global Patient Safety Compliance & Quality Specialist

Karo Healthcare, a dynamic and growing company, is committed to empowering people to make informed health decisions. With a diverse portfolio across seven categories, including medical products, we own and sell over 100 brands in approximately 90 countries. Our core belief in driving growth through organic expansion and M&A has led to rapid progress towards a €1 billion European leadership position in consumer health.

We're currently seeking a highly skilled Global Patient Safety Compliance & Quality Specialist to join our team in Stockholm, Sweden.

Key Responsibilities:
  • Ensure compliance with regulatory requirements for CA submissions to non-EU countries
  • Maintain and improve GPS ICSRs Reporting Rules
  • Act as process owner for assigned quality and compliance processes and procedures within Karo
  • Review quality, accuracy, and quality approval of Deviations and CAPAs
  • Support the Pharmacovigilance Business Continuity Plan (PV-BCP) process and testing as applicable
  • Support the PV Risk Assessment Process
  • Issue, review, and approve governing, controlling, and compliance documents and records within own areas of responsibilities and accountabilities, consistent with the global PV Quality System
  • Ensure quality control of JDs and CVs of the Global Patient Safety department
  • Support monitoring of training compliance
  • Ensure external PV partners receive applicable Karo PV SOPs/INS, and that Read & Understand is appropriately documented
  • Support maintenance of the PV Archiving System (e.g. Shared drive, SharePoint, physical archive)
  • Responsible for quality and compliance review of changes, deviation, and CAPAs and has authority to execute quality and compliance approval (or rejection) hereof
Requirements:
  • Education Level: MSc. Pharm, Medicine, or equivalent master's degree in life sciences
  • Minimum 2 years of Pharmacovigilance and/or Quality experience in the pharmaceutical industry
  • Fluent in oral and written English, and preferably one Nordic language
  • Expert in MS office (Microsoft Word, Excel, PowerPoint)
  • Knowledge of Pharmacovigilance Guidelines and Regulations
  • Experience in working with PVA management
  • Experience from a global environment and enjoying a dynamic and multitasking business environment
  • Finds joy in supporting and facilitating the Global Patient Safety Team's daily work
  • Excellent structural sense (project planning skills) and organisational abilities, prioritisation, and time management proficiencies
  • Excellent attention to details and accuracy, maintaining consistently high-quality standards
  • Able to work effectively both independently (limited supervision) and collaboratively across the organisation
  • Connecting the dots in a complex environment to make the right prioritisations and appropriate decisions. Able to identify and implement process and/or application improvements
  • Show strong evidence of our Karo values
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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