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 Global Patient Safety Compliance & Quality Specialist for our office in Stockholm, Sweden.
Roles and responsibilities
- Track compliance for CA submissions to non-EU countries
- Maintain and continuously improve GPS ICSRs Reporting Rules
- Acting as process owner of assigned quality and compliance processes and procedures within Karo
- Reviewing with regards to; quality, accuracy and when applicable, quality approval of Deviations and CAPAs
- Supporting the Pharmacovigilance Business Continuity Plan (PV-BCP) process and testing as applicable
- Supporting in the PV Risk Assessment Process
- Issuing, reviewing, and approving the governing, controlling and compliance documents and records, within own areas of responsibilities and accountabilities, consistent with the global PV Quality System
- Ensuring quality control of JDs and CVs of the Global Patient Safety department
- Support with monitoring of training compliance
- Ensuring that external PV partners receive applicable Karo PV SOPs/INS, and that Read & Understand is appropriately documented
- Supporting with 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
PVA Coordinator:
- Maintain and continuously improve GPS PVA tracker
- Maintaining GPS PVA oversight tracking, which is the source document for the PSMF Annexes, including escalating to the GPS team whenever a revision date for a PVA is emerging
- Ensuring physical archives of PVAs
- Providing PVAs to legal for documentation and archiving purposes
- Perform GVP Activity Checklist for MA Compliance for registrations, de-registrations and deactivation
- Responsible for monitoring and archiving PVA common inbox and communications
- Supportive in the PVA maintenance process e.g. establishing new routines or enhancing the processes as needed (PVA Checklist)
- Supporting the GPS team with the preparation of Pharmacovigilance Agreements (PVAs)/Safety Data Exchange Agreement templates
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.
