Global Drug Safety Physician Leader
3 days ago
Genmab is committed to developing innovative cancer treatments that change the lives of patients.
As a seasoned Pharmacovigilance Expert, you will lead critical safety evaluations and risk management activities for our ground-breaking cancer therapies. We're looking for a seasoned Medical Doctor with over 12 years of experience in drug safety/pharmacovigilance, ideally within oncology.
Key Responsibilities:
- Lead all major pre- and post-marketing safety-related activities, including signal, benefit-risk evaluation, and risk management activities for assigned Genmab products.
- Collaborate with cross-functional teams for safety assessment, ongoing surveillance, and related communication around Genmab products.
- Be responsible for handling safety issues and implementing risk mitigation activities, and propose systemic solutions.
- Provide inputs to different documents, such as trial protocols, amendments, and plans, clinical trial reports, eCRFs/CRFs, TMFs, based on review.
- Prepare relevant documentation, such as benefit/risk sections of aggregate reports, safety summaries, as per regulatory requirements.
- Lead internal & external forums, such as external Data Monitoring Committees (DMCs), Genmab Safety Committees, for assigned products.
- Provide guidance, oversight, and training around safety to relevant collaborators, such as Genmab employees, CROs, Investigators.
- Proactively engage with internal team members and external collaborators around emerging landscape, regulatory authorities around audits and inspections.
Requirements:
- MD with at least 12 years of experience in drug safety/pharmacovigilance, ideally within oncology.
- Seasoned navigator of the global PV regulatory landscape, proficient in audits, inspections, and regulatory authority interactions.
- Strategic thinker with experience in safety databases and electronic data capture systems.
- Leader who guides, mentors, and encourages teams towards excellence.
About Us:
- We're passionate about transforming the lives of patients through innovative cancer treatments.
- We bring rigor and excellence to all that we do, and are a fierce believer in our science-driven approach to problem-solving.
- We're a generous collaborator who can work in teams with diverse backgrounds.
- We're determined to do and be our best, and take pride in enabling the best work of others on the team.
- We're not afraid to grapple with the unknown and be innovative.
- We work hard and are not afraid to have a little fun while we do so.
-
Director, Global Drug Safety and Pharmacovigilance
2 months ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the Role: As the Director, Global Drug Safety & Pharmacovigilance Physician at Genmab, you will play a critical role in navigating the safety of groundbreaking cancer therapies. With a Medical Doctorate and over 12 years of experience in drug safety, ideally in oncology, you will lead critical safety evaluations and risk management activities. Your...
-
Global Safety and Pharmacovigilance Leader
2 months ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the Role: As the Director, Global Drug Safety & Pharmacovigilance Physician at Genmab, you will play a critical role in navigating the safety of groundbreaking cancer therapies. With a Medical Doctorate and over 12 years of experience in drug safety, ideally in oncology, you will lead critical safety evaluations and risk management activities. Your...
-
Global Safety and Pharmacovigilance Leader
2 months ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the Role: As the Director, Global Drug Safety & Pharmacovigilance Physician at Genmab, you will play a critical role in navigating the safety of groundbreaking cancer therapies. With a Medical Doctorate and over 12 years of experience in drug safety, ideally in oncology, you will lead critical safety evaluations and risk management activities. Your...
-
Global Drug Safety Director
2 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAt Genmab, we're dedicated to shaping the future of cancer treatment through innovative therapies. As the Director of Global Drug Safety, you'll play a critical role in ensuring the safety of our groundbreaking products. With a Medical Doctorate and over 12 years of experience in drug safety, ideally in oncology, you'll lead critical safety evaluations and...
-
Global Drug Safety Director
2 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAt Genmab, we're dedicated to pioneering innovative cancer treatments and transforming the lives of patients. As the Director of Global Drug Safety, you'll play a critical role in navigating the safety of our groundbreaking therapies. With a Medical Doctorate and over 12 years of experience in drug safety, ideally in oncology, you'll lead critical safety...
-
Global Drug Safety Director
3 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleAs a seasoned professional in drug safety and pharmacovigilance, you will play a critical role in navigating the safety of groundbreaking cancer therapies at Genmab. With a Medical Doctorate and over 12 years of experience in drug safety, ideally in oncology, you will lead critical safety evaluations and risk management activities. Your...
-
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleWe are seeking a highly skilled and experienced Director, Global Drug Safety and Pharmacovigilance to join our team at Genmab. As a key member of our organization, you will be responsible for leading critical safety evaluations and risk management activities for our innovative cancer therapies.Key ResponsibilitiesLead all major pre- and...
-
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleWe are seeking a highly skilled and experienced Director, Global Drug Safety and Pharmacovigilance to join our team at Genmab. As a key member of our organization, you will be responsible for leading critical safety evaluations and risk management activities for our innovative cancer therapies.Key ResponsibilitiesLead all major pre- and...
-
Global Safety Strategist
1 week ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAt Genmab, we foster innovation through groundbreaking cancer therapies. Our commitment to rigorous drug safety and pharmacovigilance ensures the best outcomes for patients. As a seasoned expert in global drug safety and pharmacovigilance, you will lead critical safety evaluations, risk management activities, and collaborate with cross-functional teams to...
-
Senior Manager, Global Drug Safety Operations
2 months ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout 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 timeAbout 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 timeAbout 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
3 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout 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...
-
Copenhagen, Copenhagen, Denmark Genmab Full timeAt 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...
-
Global Trust and Safety Leader
1 day ago
Copenhagen, Copenhagen, Denmark Wolt Full timeAbout 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
3 weeks ago
Copenhagen, Copenhagen, Denmark Wolt Full timeRole 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 Safety Data Manager
6 days ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout 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...
-
Global Trust and Safety Leader
2 weeks ago
Copenhagen, Copenhagen, Denmark Wolt Full timeRole 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...
-
Global Trust and Safety Leader
2 weeks ago
Copenhagen, Copenhagen, Denmark Wolt Full timeRole 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...
-
Senior Manager of Global Safety Operations
7 days ago
Copenhagen, Copenhagen, Denmark Genmab Full timeThe RoleAs 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...
