
Safety Expert
8 hours ago
We are a mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies worldwide. Our services include full-service capabilities, resourcing, and functional service solutions.
The QPPV/Safety Manager is part of the Project Delivery organization and is responsible for managing Drug Safety in accordance with company policies, SOPs, and regulatory requirements.
Key Responsibilities:
- Holding QPPV responsibilities for some clients.
- Managing Post marketing Safety-only projects.
- Preparing safety sections in various regulatory documents.
- Conducting literature reviews.
- Collecting, assessing, and entering spontaneous adverse event reports into the safety database in line with client SOPs and regulatory requirements.
- Reviewing and approving processed cases and AE/SAE reconciliations.
- Coding adverse events, medical history, and concomitant medication using MedDRA and WHO-Drug Dictionary.
- Quality checking and approving coded data.
- Electronic submission of reports to EudraVigilance.
- Contributing to post-approval surveillance plans and SOPs.
- Updating safety handling templates in line with relevant SOPs.
- Participating in relevant meetings and sharing information with relevant teams.
- Providing internal support to other departments.
- Collaborating on improvement projects with other departments.
- Contribution to organizational development and routine enhancements.
- Validation of computer applications specific to the department regarding drug safety requirements.
- Staying up-to-date on pharmacovigilance laws, directives, and guidelines.
- Mentoring and supervising new Drug Safety staff.
- Participating in marketing initiatives.
Requirements:
- Bachelor's degree in a life science or nursing field; or equivalent.
- Proven experience working as a QPPV or Deputy QPPV.
- Ability to thrive in a fast-paced environment with changing priorities.
- Familiarity with medical terminology and science related to assigned medications and therapeutic areas.
- Understanding of Pharmacovigilance legislation.
- Able to work independently and as part of a team with minimal supervision.
- Excellent written and verbal communication skills.
-
Expert in Nordic Child Safety Initiatives
9 hours ago
Stockholm, Stockholm, Sweden TN Sweden Full timeAs a Child Safety Expert Nordics, you will be responsible for leading the development of child safety initiatives across the Nordic region.Key ResponsibilitiesShape the future of child safety across the Nordic region.Drive PR strategies and build contacts to enhance Cybex's visibility as a leading child safety expert among consumers.Collaborate with the CTPS...
-
Metal Safety and Security Expert
1 day ago
Stockholm, Stockholm, Sweden Boliden Mineral AB Full timeAt Boliden, we take pride in our commitment to safety and security across all aspects of our operations. As a proactive and strategic Safety and Security Specialist, you will play a crucial role in ensuring the success of our safety and security measures. This involves driving strategic development in safety and security at Boliden Smelters, implementing and...
-
Nordic Food Safety and Quality Expert
9 hours ago
Stockholm, Stockholm, Sweden TN Sweden Full timeCoca-Cola Europacific Partners (CCEP) is committed to delivering exceptional quality and safety standards across our European operations. As a Nordic Food Safety and Quality Expert, you will play a critical role in driving quality and safety initiatives, collaborating with cross-functional teams, and promoting a culture of quality and safety throughout the...
-
Senior Chemical Safety Expert
7 days ago
Stockholm, Stockholm, Sweden FM Full timeJob SummaryThis is a dynamic opportunity for a Senior Chemical Safety Expert to join our team and work independently at client locations, including some of the largest industrial facilities worldwide, to prevent losses and provide guidance on engineering and environmental risk topics.
-
Railway Safety Engineer
9 hours ago
Stockholm, Stockholm, Sweden Alstom Full timeSafety Assurance ExpertAt Alstom, we prioritize safety above all else, and we're seeking a seasoned Safety Assurance Expert to join our team. This critical role involves ensuring the safety of our products and services by identifying and mitigating risks throughout their lifecycle.As a key member of our team, you'll be responsible for:Developing and...
-
Safety and Compliance Engineer
9 hours ago
Stockholm, Stockholm, Sweden Intertek Semko AB Full timeIntertek Semko AB is a leading provider of testing and certification services for products across various industries. We're seeking a talented Safety and Compliance Engineer to join our team and contribute to the evaluation of products to ensure compliance with electrical safety standards.As a Safety and Compliance Engineer, you'll work closely with junior...
-
Senior Electrical Safety Specialist
9 hours ago
Stockholm, Stockholm, Sweden Intertek Semko AB Full timeAt Intertek Semko AB, we're looking for a highly skilled Senior Electrical Safety Specialist to join our team of experts in machinery safety. As a key member of our Industry team, you'll play a vital role in evaluating products to ensure compliance with electrical safety standards.You'll work closely with junior and senior engineers to analyze technical...
-
Railway Safety Expert
9 hours ago
Stockholm, Stockholm, Sweden ALSTOM Gruppe Full timeSafety Assurance RoleThe successful candidate will be responsible for managing, performing, and ensuring safety-related activities throughout the lifecycle of our products and subsystems.Coordinate all safety assurance activities on the project, system, or product as per the defined safety process.Undertake product safety assessments, manage Hazard Log,...
-
Nordic Child Safety Specialist
9 hours ago
Stockholm, Stockholm, Sweden TN Sweden Full timeWe recognize the importance of child safety across the Nordic region. As a Child Safety Expert Nordics, you will play a key role in shaping our future initiatives.ResponsibilitiesCollaborate with strategic stakeholders in all four Nordic countries, including traffic safety organizations and political figures.Lead the training and education of the Nordic...
-
Nordic Quality and Food Safety Director
7 days ago
Stockholm, Stockholm, Sweden Coca-Cola Europacific Partners Full timeAbout UsCoca-Cola Europacific Partners is a dedicated team of 42,000 people serving customers in 31 countries. We work together to make, move, and sell some of the world's most loved brands.Our TeamOur team is passionate about quality and food safety, and we're looking for someone who shares this passion. As the Quality & Food Safety Lead, you will be...
-
Machinery Safety Assurance Professional
7 days ago
Stockholm, Stockholm, Sweden Intertek Semko AB Full timeAs a Machinery Safety Assurance Professional at Intertek Semko AB, you'll play a vital role in ensuring the safety and compliance of our clients' electrical equipment.In this role, you'll be responsible for conducting evaluations, assessments, and tests to verify compliance with regulatory standards. You'll also provide expert guidance on machinery-related...
-
Product Safety Certification Engineer
7 days ago
Stockholm, Stockholm, Sweden Intertek Semko AB Full timeAs a Product Safety Certification Engineer at Intertek Semko AB, you'll be responsible for ensuring the safety and compliance of our clients' electrical equipment.In this role, you'll conduct evaluations, assessments, and tests to verify compliance with regulatory standards. You'll also provide expert guidance on machinery-related queries to internal teams...
-
Safety Documentation Expert
7 days ago
Stockholm, Stockholm, Sweden Blykalla Full timeWe are Blykalla, Sweden's leader in the development of innovative Advanced Reactors. Our mission is to create a new generation of nuclear energy systems that are safer, more efficient, and environmentally friendly.We are seeking a highly skilled Nuclear Safety Specialist to join our team and contribute to this mission. As a key member, you will be...
-
Child Safety Professional for the Nordics
9 hours ago
Stockholm, Stockholm, Sweden TN Sweden Full timeAs a Child Safety Expert Nordics, you will play a key role in shaping our child safety initiatives across the Nordic region.Key RequirementsBackground in the child safety industry (e.g., manufacturing/brand, insurance company, automobile club, or traffic safety organization).Strong fact-based and insight-driven mindset.A sales-oriented profile, with the...
-
Regulatory Approvals and Safety Specialist
7 days ago
Stockholm, Stockholm, Sweden Ericsson GmbH Full timeSafety Engineer Regulatory Compliance ExpertAbout this role:As a key member of our Product Engineering Unit Radio (PEU Radio) within Business Area Networks, we are seeking a highly skilled Safety Engineer Regulatory Compliance Expert.The primary focus of this role is to ensure that our new Radio Hardware/Software meets regulatory requirements for market...
-
Product Safety Expert
8 hours ago
Stockholm, Stockholm, Sweden Alfa Laval Full timeAbout the JobAlfa Laval is a pioneering company in the field of sustainable solutions for various industries. As a Product Compliance Specialist, you will be part of the Compliance function in the Business Unit High-Speed Separators.Your primary responsibility will be to ensure that our products meet all relevant regulatory and safety standards. This...
-
Food Safety and Quality Lead Europe
9 hours ago
Stockholm, Stockholm, Sweden TN Sweden Full timeCoca-Cola Europacific Partners is seeking an experienced Food Safety and Quality Lead to drive excellence across our European business unit. In this critical role, you will lead the development and implementation of quality and safety strategies, ensuring compliance with regulatory requirements and industry best practices.This position involves collaborating...
-
Senior Rail Safety Expert
57 minutes ago
Stockholm, Stockholm, Sweden ALSTOM Gruppe Full timeCompany OverviewALSTOM Gruppe has been shaping the future of transportation for decades. Our diverse portfolio includes high-speed trains, metros, monorails, and trams, as well as turnkey systems, services, infrastructure, signalling and digital mobility.We operate in 63 countries, employing over 80,000 colleagues worldwide. Our goal is to make transport...
-
Senior Machinery Safety Specialist
7 days ago
Stockholm, Stockholm, Sweden Intertek Semko AB Full timeAt Intertek Semko AB, we're looking for a Senior Machinery Safety Specialist to join our team. As a key member of our organization, you'll play a crucial role in ensuring the safety and compliance of our clients' electrical equipment.As a Senior Machinery Safety Specialist, you will:Analyze technical documentation to identify potential safety risks in...
-
Head of Drug Safety
14 hours ago
Stockholm, Stockholm, Sweden PharmaRelations ApS Full timePharmaRelationsNordics - StockholmApply nowPharmaRelations is the market leading Life Science Group in the Nordics. Operating across the Nordics with offices in Sweden, Denmark, Finland, and Norway, we provide expert services that span clinical to post-marketing phases. Our Clinical Business Unit is expanding, and we are seeking a Head of Safety to lead our...