Kristian Vatne
Business Development Manager Rx at Karo Pharma- Claim this Profile
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Credentials
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Duolingo Spanish Fluency: Intermediate (Estimated)
DuolingoNov, 2015- Sep, 2024 -
Duolingo Spanish Fluency: Intermediate (Estimated)
DuolingoNov, 2015- Sep, 2024 -
Certified ScrumMaster (CSM)
Scrum AllianceNov, 2019- Sep, 2024
Experience
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Karo Pharma
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Sweden
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Business Development Manager Rx
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Aug 2021 - Present
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Roche
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Switzerland
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Biotechnology Research
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700 & Above Employee
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Country Study Manager
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Mar 2021 - Jul 2021
Planning, initiation, and implementation of clinical studies
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Local Safety Responsible
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Dec 2019 - Jul 2021
PV Approver for Market Research and Patient Support Programs (MAPs) Oversight of PV compliance across all processes PV Training and PV procedural documents management Management of deviations and coordination of CAPA implementation Monitoring and Oversight of Service Provider Management/Outsourcing process Approval of PV agreements with GVP/GCP Service providers and clinical study partners Coordination of reconciliations: Roche safety database vs Roche clinical… Show more PV Approver for Market Research and Patient Support Programs (MAPs) Oversight of PV compliance across all processes PV Training and PV procedural documents management Management of deviations and coordination of CAPA implementation Monitoring and Oversight of Service Provider Management/Outsourcing process Approval of PV agreements with GVP/GCP Service providers and clinical study partners Coordination of reconciliations: Roche safety database vs Roche clinical database; vs Roche medical information database, vs Roche quality database and vs vendors database. Implementation of PV requirements for digital activities and channels: websites, social medias, applications and digital listening activities Ensures appropriate safety reporting processes are in place at affiliate level and, if applicable, described in relevant local documents, for global and local interventional clinical trials, Non-Interventional Studies (NISs), Post Authorization Studies (PASS/PAES), Market Research and Patient Support Programs (MAPs), Pre-Approval and Post-Trial Access Programs and Compassionate Use in accordance with Roche policies and procedures, global and local regulatory requirements. PV inspection readiness
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Regulatory Affairs Manager
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Apr 2019 - Dec 2019
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Product Manager
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Jan 2019 - Dec 2019
• Leading the preparation for the launch of two products • Developing and executing the marketing strategy for the launch • Market Analysis; monitoring trends, competitive activities and developing effective KPI
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Drug Safety & Medical Information Manager
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Aug 2018 - Aug 2019
Drug Safety & Medical Information Manager Oslo, Norge • Deputy Local Safety Responsible • Pharmacovigilance Approver and process owner of Market Research and Patient Support Program (MAP) • Risk Management Plan Implementation Coordinator
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Alliance Healthcare
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United States
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Hospitals and Health Care
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Pharmacist, security of supply
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Jun 2017 - Jul 2018
Alliance Healthcare Norway, is the largest pharmaceutical wholesaler in Norway and delivers medicines to all hospitals and hospital pharmacies in Norway, as well as the pharmacy chain, Boots Norway. Alliance Healthcare's most important responsibility as a drug wholesale company is to ensure that pharmacies and hospitals have access to critical drugs at all time. I worked in the department of unlicensed medicines (medicines without MA in Norway), and one of my main responsibilities was to… Show more Alliance Healthcare Norway, is the largest pharmaceutical wholesaler in Norway and delivers medicines to all hospitals and hospital pharmacies in Norway, as well as the pharmacy chain, Boots Norway. Alliance Healthcare's most important responsibility as a drug wholesale company is to ensure that pharmacies and hospitals have access to critical drugs at all time. I worked in the department of unlicensed medicines (medicines without MA in Norway), and one of my main responsibilities was to manage and prevent drug shortages. Preventing drug shortages: identifying the most effective key performance indicators for describing the performance of Alliance Healthcare's ability to supply critical drugs. Measure and monitor the KPIs, and develop strategies to improve the supply chain performance. Managing drug shortages: assessing the impact of the drug shortage, examine the possibility of obtaining the medicine in other market, or alternative product, to avoid disruptions in patient care and to provide uninterrupted therapy. Key responsibilities: - Developing supply chain strategies - Contribute to the development of Alliance Healthcare's supplier portfolio - Monitor supplier performance and managing key relationships Show less Alliance Healthcare Norway, is the largest pharmaceutical wholesaler in Norway and delivers medicines to all hospitals and hospital pharmacies in Norway, as well as the pharmacy chain, Boots Norway. Alliance Healthcare's most important responsibility as a drug wholesale company is to ensure that pharmacies and hospitals have access to critical drugs at all time. I worked in the department of unlicensed medicines (medicines without MA in Norway), and one of my main responsibilities was to… Show more Alliance Healthcare Norway, is the largest pharmaceutical wholesaler in Norway and delivers medicines to all hospitals and hospital pharmacies in Norway, as well as the pharmacy chain, Boots Norway. Alliance Healthcare's most important responsibility as a drug wholesale company is to ensure that pharmacies and hospitals have access to critical drugs at all time. I worked in the department of unlicensed medicines (medicines without MA in Norway), and one of my main responsibilities was to manage and prevent drug shortages. Preventing drug shortages: identifying the most effective key performance indicators for describing the performance of Alliance Healthcare's ability to supply critical drugs. Measure and monitor the KPIs, and develop strategies to improve the supply chain performance. Managing drug shortages: assessing the impact of the drug shortage, examine the possibility of obtaining the medicine in other market, or alternative product, to avoid disruptions in patient care and to provide uninterrupted therapy. Key responsibilities: - Developing supply chain strategies - Contribute to the development of Alliance Healthcare's supplier portfolio - Monitor supplier performance and managing key relationships Show less
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PHARMAQ
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Greece
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Pharmaceutical Manufacturing
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Quality Assurance Manager
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Nov 2015 - Jun 2017
PHARMAQ is the global leader in vaccines and innovation for aquaculture and part of Zoetis, the world leader in animal health. I worked as the QA Manager at the GMP production site for antiviral vaccines. My key responsibilities were: • Establishing, maintaining and continuously improving the quality system according to cGMP • Performing and participating in internal audit • Maintain schedule calendars to stay on track with GMP training and quality management review •… Show more PHARMAQ is the global leader in vaccines and innovation for aquaculture and part of Zoetis, the world leader in animal health. I worked as the QA Manager at the GMP production site for antiviral vaccines. My key responsibilities were: • Establishing, maintaining and continuously improving the quality system according to cGMP • Performing and participating in internal audit • Maintain schedule calendars to stay on track with GMP training and quality management review • Manage the productions site's training program by coordinating the schedule and maintaining all records • Defining, coordinating and documenting the interface between PHARMAQ and NIPH quality systems, roles and responsibilities • Qualification of temperature-controlled rooms at the new production facilities at Kløfta Show less PHARMAQ is the global leader in vaccines and innovation for aquaculture and part of Zoetis, the world leader in animal health. I worked as the QA Manager at the GMP production site for antiviral vaccines. My key responsibilities were: • Establishing, maintaining and continuously improving the quality system according to cGMP • Performing and participating in internal audit • Maintain schedule calendars to stay on track with GMP training and quality management review •… Show more PHARMAQ is the global leader in vaccines and innovation for aquaculture and part of Zoetis, the world leader in animal health. I worked as the QA Manager at the GMP production site for antiviral vaccines. My key responsibilities were: • Establishing, maintaining and continuously improving the quality system according to cGMP • Performing and participating in internal audit • Maintain schedule calendars to stay on track with GMP training and quality management review • Manage the productions site's training program by coordinating the schedule and maintaining all records • Defining, coordinating and documenting the interface between PHARMAQ and NIPH quality systems, roles and responsibilities • Qualification of temperature-controlled rooms at the new production facilities at Kløfta Show less
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Boots Norge AS
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Norway
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Retail
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Pharmacist
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Jun 2012 - May 2017
• Part-time job after school and full-time in holidays. I spent my internship at Boots Askim • Worked Saturdays at Boots Høvik from November 2015 till July 2018 • Part-time job after school and full-time in holidays. I spent my internship at Boots Askim • Worked Saturdays at Boots Høvik from November 2015 till July 2018
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Education
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Københavns Universitet - University of Copenhagen
Cand.pharm, Pharmacy -
University of Groningen
Dutch Language Courses for Native Speakers of German -
University of Groningen
International Economics and Business -
Bjørknes College
English and Biology -
Oslo Private Gymnasium