Global Patient Safety Surveillance Specialist

3 days ago


Stockholm, Stockholm, Sweden Karo Healthcare Full time
Global Patient Safety Surveillance Specialist

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 core belief in empowering people to make intelligent health decisions drives our growth strategy, blending organic expansion and M&A.

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 and 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, writes and reviews 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 presents 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 communicates potential safety issues in the Surveillance Team
  • Provides 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.

Seniority level: Associate

Employment type: Full-time

Job function: Product Management

Industries: Non-profit Organizations and Primary and Secondary Education

#J-18808-Ljbffr

  • Stockholm, Stockholm, Sweden Karo Healthcare Full time

    Global Patient Safety AnalystAbout the Role:We are seeking a highly skilled Global Patient Safety Analyst to join our team at Karo Healthcare. As a key member of our Safety Surveillance & Risk Management department, you will play a critical role in ensuring the highest quality and timeliness of all activities under your responsibility.Key...


  • Stockholm, Stockholm, Sweden Karo Healthcare Full time

    Healthcare Surveillance ExpertCompany Overview:Karo Healthcare is a dynamic and growing company that empowers people to make intelligent health decisions. With a wide-ranging portfolio across seven categories, we own and sell over 80 brands in about 90 countries.Job Description:The Global Patient Safety Surveillance Specialist will be responsible for having...


  • Stockholm, Stockholm, Sweden Karo Healthcare Full time

    Job DescriptionWe are seeking a skilled Global Patient Safety Risk Manager to join our team at Karo Healthcare. As a key member of our Pharmacovigilance department, you will be responsible for ensuring the safety of our medicinal products.Key Responsibilities:Overseeing the safety profiles and risk-benefit evaluations of our medicinal products during their...


  • Stockholm, Stockholm, Sweden Karo Healthcare Full time

    About UsKaro Healthcare is a dynamic and growing company dedicated to making smart choices for everyday healthcare. With a wide-ranging portfolio across seven categories, we own and sell over 80 brands in about 90 countries.We believe in empowering people to make intelligent health decisions, driving our growth strategy by blending organic expansion and...


  • Stockholm, Stockholm, Sweden Karo Healthcare Full time

    Medical Safety ProfessionalRole Overview:This role requires a highly skilled Medical Safety Professional to lead the Safety Surveillance & Risk Management department at Karo Healthcare. As a key member of the team, you will be responsible for ensuring the highest quality and timeliness of all activities under your responsibility.Main...


  • Stockholm, Stockholm, Sweden EarthStream Global Full time

    Job DescriptionThe Industrial Safety Specialist is responsible for ensuring the safety of our production processes, adhering to legislative requirements and industry best practices.This role involves reviewing safety designs, coordinating with stakeholders, and carrying out risk analyses. The successful candidate will work closely with project teams,...


  • Stockholm, Stockholm, Sweden Karo Healthcare Full time

    OverviewKaro Healthcare is committed to delivering innovative solutions that improve patient outcomes and enhance the quality of life. Our core mission is to empower people to make intelligent health decisions, driving our growth strategy by blending organic expansion and M&A.With a wide-ranging portfolio across seven categories, we own and sell over 80...


  • Stockholm, Stockholm, Sweden Karo Healthcare Full time

    About the RoleWe are seeking a skilled Risk Management Specialist to join our team at Karo Healthcare. As a key member of our Pharmacovigilance department, you will be responsible for ensuring the safety of our medicinal products.Key Responsibilities:Overseeing the safety profiles and risk-benefit evaluations of our medicinal products during their...


  • Stockholm, Stockholm, Sweden Karo Healthcare Full time

    Pharmacovigilance SpecialistAbout Us:Karo Healthcare has a strong belief in empowering people to make intelligent health decisions. Our growth strategy blends organic expansion and M&A, driving us to become a leading player in the industry.Job Summary:We are seeking a Pharmacovigilance Specialist to join our Safety Surveillance & Risk Management department....


  • Stockholm, Stockholm, Sweden Vipas Full time

    Welcome to Vipas AB, where we strive to create innovative solutions using cutting-edge technologies like Java and Python.We are seeking a highly skilled Reliability and Safety Specialist to join our team in the heavy vehicle domain.As a Reliability and Safety Specialist, you will be responsible for ensuring the safety and reliability of our products,...


  • Stockholm, Stockholm, Sweden Eccoci AB Full time

    Eccoci AB is looking for an Industrial Safety Specialist to join our consultant team in Stockholm. The ideal candidate will have extensive experience in gas processing and a proven track record in developing and implementing safety designs.About the AssignmentAs an Industrial Safety Specialist, you will play a key role in reviewing the safety of design and...


  • Stockholm, Stockholm, Sweden Alcott Global Full time

    Job OverviewAlcott Global is seeking a highly experienced Global VP of Manufacturing to lead the company's global production operations. The successful candidate will be responsible for overseeing and optimizing manufacturing processes across all production facilities worldwide.About the RoleThe Vice President of Global Production will drive efficiency,...


  • Stockholm, Stockholm, Sweden EarthStream Global Full time

    About the RoleThe Safety Design Engineer is an integral part of our team, responsible for ensuring the safe design of our production processes.This involves reviewing safety designs, coordinating with stakeholders, and carrying out risk analyses. The successful candidate will work closely with project teams, operation, EPCMs, OEMs, and regulatory...


  • Stockholm, Stockholm, Sweden EarthStream Global Full time

    Engineering Safety ProfessionalThis role is responsible for ensuring the safe design and operation of our production processes. The successful candidate will work closely with project teams, operation, EPCMs, OEMs, and regulatory authorities.Responsibilities:Designing and implementing safety protocols to mitigate risksCollaborating with stakeholders to...


  • Stockholm, Stockholm, Sweden Swediumglobal Full time

    Sweedum Global offers a wide range of services, including System Engineering, R&D Services, Embedded Systems Development, Custom Application Software Development, and more.Position: Functional Safety SpecialistKey Responsibilities:Designing and developing safety-critical systemsConducting thorough risk assessments and safety analysesImplementing Functional...


  • Stockholm, Stockholm, Sweden Blykalla Full time

    We are seeking a highly experienced Nuclear Safety Specialist to guide the development and execution of our safety protocols. This role involves leading risk assessments, collaborating with cross-functional teams, and ensuring that Blykalla meets or exceeds all regulatory requirements.Company Overview:Blykalla AB is transforming the future of nuclear power...


  • Stockholm, Stockholm, Sweden Swediumglobal Full time

    Sweedum Global is a renowned provider of System Engineering and Solution services, offering expertise in Semiconductor Engineering R&D Services, Embedded Systems Development, Custom Application Software Development, Web and Cloud Application Development, Testing Services, Consultancy, and Outsourcing services to clients worldwide.Location: RemoteJob Role:...


  • Stockholm, Stockholm, Sweden TN Sweden Full time

    We are seeking a highly skilled Food Safety Specialist to join our team at TN Sweden. As a key member of our organization, you will be responsible for reviewing and approving suppliers' documents related to food safety legislation.Key Responsibilities:Provide expert advice on materials and parts in contact with foodDevelop model formulations and maintain...


  • Stockholm, Stockholm, Sweden VIPAS AB Full time

    At VIPAS AB, we're on a mission to deliver cutting-edge IT consulting services. As a Food Safety & Compliance Specialist, you'll play a crucial role in ensuring our suppliers adhere to food safety regulations.Job DescriptionWe're looking for a highly skilled professional to review and approve suppliers' documents related to applicable food safety...


  • Stockholm, Stockholm, Sweden Vipas Full time

    About Vipas ABVipas AB is a pioneering IT consulting company that specializes in delivering tailored solutions using cutting-edge technologies like Java and Python. Our team of experts brings years of experience and expertise in software development, DevOps, and engineering.We're seeking a highly skilled Food Safety Specialist to review and approve...