Senior Manager of Global Safety Operations

7 days ago

Copenhagen, Copenhagen, Denmark Genmab Full time

The Role



As a Senior Manager of Global Safety Operations, you will be a member of the Global Drug Safety & Pharmacovigilance team, focused on safety operations including but not limited to collection of safety information from various sources, SAE reconciliation, quality control of safety data entry, and compliance of individual case safety reports (ICSRs) to regulatory authorities and business partners.



Key Responsibilities:


  • Oversee the successful and timely case intake of safety reports and case processing
  • Perform ongoing and real-time quality control review of safety case data entry in the safety database in compliance with the data entry conventions and MedDRA/WHO DD coding conventions
  • Provide guidance on questions around safety operations based on not only company conventions, but also ICH and regulatory guidance as well as the best PV practices. Safety operation related questions include but not limited to: case processing; regulatory submissions of Individual Case Safety Reports to regulatory authorities, ethics committees, investigators, and other stakeholders; data entry or safety queries; collection of safety information
  • Develop or update Standard Operating Procedures, Working Instructions, and training materials around safety case processing and operations
  • Oversee and manage SAE Reconciliation activities including review and approval of the reconciliation plan and generation of SAE reconciliation listings
  • Effectively manage safety case workload to ensure compliance with regulatory submissions and internal timelines
  • Perform investigation of deviations and monitoring of Corrective Actions/Preventive Actions (CAPAs) relating to non-compliance issues and findings, as well as assess the effectiveness of the CAPAs
  • Oversee open and answered safety queries in the EDC and timely resolution of safety queries
  • Review and provide input on Safety Operational Management Plan on behalf of Safety Operations
  • Perform User Acceptance Test (UAT) on Safety Related Forms in EDC, ensuring correct dynamics and edit checks
  • Provide comments on the e-Safety Reporting Form Specifications document and perform UAT
  • Generate aggregate and ad-hoc reports for responsible products
  • Oversee other activities related safety operations including ICSR submission or distribution to ECs/IRBs/Investigators/Business Partners
  • Other activities, as needed or as requested by supervisor


Requirements:


  • Drug Safety professional with minimum 5 years of experience within drug safety and PV inclusive of case quality control and regulatory submissions of ICSRs worldwide
  • Good knowledge of ICH E2B(R2) and (R3) specifications and entry guidance
  • Ability to interpret health and medical records such as adverse event reporting forms, a discharge summary, etc
  • Good knowledge of pharmacovigilance reporting rules and timelines
  • Experience with clinical and post-marketing case processing, including MedDRA and WHO DD coding and narrative writing
  • Experience with safety database; Argus is a plus but not mandatory
  • Experience with EDC for clinical trial data collection
  • Analytic and strategic thinking
  • Excellent in detailed-oriented tasks

This role is located in Copenhagen, Denmark and is hybrid.

  • Senior Manager, Global Drug Safety Operations

    3 weeks ago

    Copenhagen, Copenhagen, Denmark Genmab Full time

    About the RoleWe are seeking a highly skilled Senior Manager to join our Global Drug Safety and Pharmacovigilance team. As a key member of our team, you will be responsible for overseeing the successful and timely case intake of safety reports and case processing.Key ResponsibilitiesOversee the successful and timely case intake of safety reports and case...

  • Senior Manager, Global Drug Safety Operations

    2 months ago

    Copenhagen, Copenhagen, Denmark Genmab Full time

    About the RoleWe are seeking a highly skilled Senior Manager, Global Drug Safety to join our team at Genmab. As a key member of our Global Drug Safety & Pharmacovigilance team, you will be responsible for overseeing the successful and timely case intake of safety reports and case processing.Key ResponsibilitiesOversee the collection of safety information...

  • Senior Manager, Global Drug Safety Operations

    1 month ago

    Copenhagen, Copenhagen, Denmark Genmab Full time

    About the RoleWe are seeking a highly skilled Senior Manager, Global Drug Safety to join our team at Genmab. As a key member of our Global Drug Safety and Pharmacovigilance team, you will be responsible for overseeing the successful and timely case intake of safety reports and case processing.Key ResponsibilitiesOversee the successful and timely case intake...

  • Senior Manager, Global Drug Safety Operations

    3 weeks ago

    Copenhagen, Copenhagen, Denmark Genmab Full time

    About the RoleWe are seeking a highly skilled Senior Manager to join our Global Drug Safety team at Genmab. As a key member of our team, you will be responsible for overseeing the successful and timely case intake of safety reports and case processing.Key ResponsibilitiesOversee the successful and timely case intake of safety reports and case...

  • Senior Manager, Safety Surveillance Lead

    2 months ago

    Copenhagen, Copenhagen, Denmark Lundbeck Full time

    About the RoleWe are seeking a highly skilled and experienced Senior Manager, Safety Surveillance to join our team at Lundbeck. As a key member of our Global Patient Safety department, you will be responsible for providing scientific and functional leadership to a team of Safety Scientists.Key ResponsibilitiesDevelop and enhance the understanding of the...

  • Senior Manager, Global Drug Safety and Pharmacovigilance

    3 weeks ago

    Copenhagen, Copenhagen, Denmark Genmab Full time

    At Genmab, we're committed to building extraordinary futures together, by developing innovative antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases. Our people are caring, candid, and impact-driven, and our business is innovative and rooted in science. We believe that being...

  • Senior Manager, Safety Surveillance Lead

    1 month ago

    Copenhagen, Copenhagen, Denmark Lundbeck Full time

    About the RoleWe are seeking a highly skilled and experienced Senior Manager, Safety Surveillance to join our Global Patient Safety team at Lundbeck. As a key member of our leadership team, you will be responsible for providing scientific and functional leadership to a team of Safety Scientists, ensuring the development and enhancement of the understanding...

  • Global Safety Data Manager

    6 days ago

    Copenhagen, Copenhagen, Denmark Genmab Full time

    About UsGenmab is a biotechnology company dedicated to developing innovative antibody products that transform the lives of patients with cancer and other serious diseases. Our work is driven by a passion for making a difference and a commitment to excellence in everything we do.The RoleWe are seeking a skilled Global Safety Data Manager to join our Global...

  • Technical Operations Manager

    3 weeks ago

    Copenhagen, Copenhagen, Denmark EcoPlanet Green Operations GmbH Full time

    Job Title: Technical Operations ManagerCBRE Global Workplace Solutions is a leading provider of integrated real estate, facilities, and technology solutions. As a dedicated business line within CBRE, GWS is committed to delivering exceptional service and solving complex challenges in the real estate lifecycle.We offer our employees a dynamic and supportive...

  • Senior Manager, Safety Surveillance Lead

    2 weeks ago

    Copenhagen, Copenhagen, Denmark Lundbeck Full time

    Senior Manager, Safety Surveillance LeadAre you a seasoned leader with a passion for empowering teams to excel in data-driven environments? Do you have a strong background in drug development and patient safety?This role offers a unique opportunity to lead a team of Safety Scientists in developing and enhancing the understanding of the asset's safety...

  • Head of Global Trust and Safety

    4 weeks ago

    Copenhagen, Copenhagen, Denmark Wolt Full time

    Role OverviewWolt is seeking a seasoned professional to lead its Global Trust and Safety team, responsible for mitigating trust and safety risks on the platform. As the Head of Global Trust and Safety, you will develop and execute comprehensive strategies to enhance safety and trust across the entire ecosystem.Key ResponsibilitiesDesign and build a...

  • Global Trust and Safety Leader

    1 day ago

    Copenhagen, Copenhagen, Denmark Wolt Full time

    About the RoleWe are seeking a skilled professional to lead our Global Trust and Safety Team at Wolt. As the Head of Global Trust and Safety, you will be responsible for driving the development and execution of comprehensive strategies, policies, and initiatives that enhance safety and trust across our entire ecosystem.Key Responsibilities:Design and build a...

  • Global Trust and Safety Leader

    2 weeks ago

    Copenhagen, Copenhagen, Denmark Wolt Full time

    Role OverviewWolt is seeking a seasoned professional to lead its Global Trust and Safety team. As the Head of Trust and Safety, you will be responsible for developing and executing comprehensive strategies to enhance safety and trust across our entire ecosystem.Key ResponsibilitiesDesign and build a Global Trust and Safety Team that collaborates with other...

  • Head of Global Trust and Safety

    1 month ago

    Copenhagen, Copenhagen, Denmark Wolt Full time

    About the RoleWe are seeking a highly experienced and skilled professional to lead our Global Trust and Safety team at Wolt. As the Head of Global Trust and Safety, you will be responsible for driving the development and execution of comprehensive strategies, policies, and initiatives that enhance safety and trust across our entire ecosystem.Key...

  • Global Trust and Safety Strategist

    2 weeks ago

    Copenhagen, Copenhagen, Denmark Wolt Full time

    Role OverviewWolt is seeking a seasoned professional to lead its Global Trust and Safety team. As the Head of Global Trust and Safety, you will be responsible for developing and executing comprehensive strategies, policies, and initiatives that enhance safety and trust across our entire ecosystem.Key ResponsibilitiesDesign and build a Global Trust and Safety...

  • Global Trust and Safety Director

    2 weeks ago

    Copenhagen, Copenhagen, Denmark Wolt Full time

    About Trust and Safety at WoltWolt is a global food delivery and grocery market company that prioritizes trust and safety for all users. We're seeking a seasoned professional to lead our Trust and Safety team and drive initiatives that enhance safety and trust across our ecosystem.Key ResponsibilitiesDesign and build a high-performing Global Trust and Safety...

  • Global Trust and Safety Leader

    3 weeks ago

    Copenhagen, Copenhagen, Denmark Wolt Full time

    Role OverviewWolt is seeking a seasoned professional to lead its Global Trust and Safety team, responsible for mitigating trust and safety risks on the platform. As the Head of Global Trust and Safety, you will develop and execute comprehensive strategies, policies, and initiatives to enhance safety and trust across the ecosystem.Key ResponsibilitiesDesign...

  • Global Trust and Safety Leader

    2 weeks ago

    Copenhagen, Copenhagen, Denmark Wolt Full time

    Role OverviewWolt is seeking a seasoned professional to lead its Global Trust and Safety team. As the Head of Trust and Safety, you will be responsible for developing and executing comprehensive strategies, policies, and initiatives that enhance safety and trust across our entire ecosystem.Key ResponsibilitiesDesign and build a Global Trust and Safety Team...

  • Global Safety and Security Director

    1 week ago

    Copenhagen, Copenhagen, Denmark Wolt Full time

    Role OverviewWolt is seeking an experienced professional to lead its Global Trust and Safety team. The successful candidate will have a deep understanding of safety and compliance principles and be able to develop and implement strategies to mitigate risks across the platform.Key ResponsibilitiesDevelop and launch policies to guide customer, courier partner,...

  • Senior HSE Manager

    3 weeks ago

    Copenhagen, Copenhagen, Denmark Maersk Group - A.P. Møller Mærsk Full time

    Maersk is seeking a dedicated Senior HSE Manager to define, own, and facilitate the implementation of the global APMM HSSE management framework across our operations. The role also serves as the HSE expert within warehouse and depot operations who prioritises occupational health, safety, and environmental standards.Key Responsibilities:As the Senior HSE...