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 80 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 Surveillance Specialist for our headquarter office in Stockholm, Sweden.
Roles and responsibilities
- Having an overview of the medicinal product safety profiles and risk-benefit evaluations during its lifecycle
- Ensuring all activities under own responsibility are fulfilled to high quality an in a timely manner within Safety Surveillance & Risk Management
- Ensuring all activities under own responsibility within Safety Surveillance & Risk Management for Karo products and with 3rd partners with whom Karo hold a Safety Data Exchange Agreements (SDEA)/ Pharmacovigilance Agreement (PVA)
- Supports EU & UK QPPV/deputy to enable the QPPV to maintain oversight of the PV system, in particular for Patient Safety surveillance activities
- Provides aggregate data, write and review e.g. PBRER, PSUR, DSUR, Addendum to Clinical overview, for Karo's medicinal products
- Writes, reviews, or contributes to the Risk Management Plans (RMPs) and any risk minimisation measures
- Performs signal validation and further signal assessment activities as applicable, and contributes to the Company Core Safety Information (CCSI) management
- Brings suspected safety concerns to Safety Review Board and present signal detection & validation activities to the Safety Review Board
- Contributes to safety signal management processes continuously improved to reflect regulatory trends and guidelines
- Identifies and communicate potential safety issues in the Surveillance Team
- Provide input to continuous improvement of KARO's systems related to surveillance activities
- Performs PV intelligence activities related to surveillance according to Karo processes
- Contributes with own area of expertise during geo-expansion and acquisitions
Requirements
- MSc. Pharm, Medicine, or equal master in life science
- Minimum 3 years of Pharmacovigilance (post-marketing) experience in the pharmaceutical industry
- Experience in Aggregated Reports and Signal Management Merits
- Fluent in oral and written English
- Expert in MS office (Microsoft Word, Excel, PowerPoint)
- Experience of Veeva Vault Safety
- Knowledge of Pharmacovigilance Guidelines and Regulations
- Enjoying a dynamic and multitasking business environment
- Strong structural sense (project planning skills) and organisational abilities, prioritisation, and time management proficiencies
- Attention to details and accuracy, maintaining consistently high-quality standards
- Able to work effectively both independently (limited supervision) and collaboratively across the organisation
- Able to identify and implement process and/or application improvements
- Problem solving attitude and the ability to successfully execute in a dynamic environment
- Show strong evidence of our Karo value
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, hybrid model with the primary work place in the office, 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 dynamic, 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.
