Associate Director, Global Drug Safety Expert
2 weeks ago
We are seeking an experienced Associate Director to join our Global Drug Safety team at Genmab. As a key member of our team, you will be responsible for leading major pre- and post-marketing safety-related activities, including signal identification and assessment, benefit-risk evaluation, and risk management activities.
Key Responsibilities- Lead all major pre- and post-marketing safety-related activities, including signal identification and assessment, benefit-risk evaluation, and risk management activities.
- Effectively collaborate with drug safety and cross-functional teams for safety assessments, ongoing surveillance, and related communication around assigned Genmab products.
- Oversee handling of safety issues and implementing risk mitigation activities.
- Provide inputs to different documents, such as trial protocols, amendments, and plans, clinical trial reports, eCRFs, and TMFs, based on review.
- Prepare relevant documentation, such as benefit/risk sections of aggregate reports, safety summaries, and Q&As, as per regulatory requirements.
- Manage internal and external forums, such as external Data Monitoring Committees and Genmab Safety Committees, for assigned products.
- Provide guidance, oversight, and training around safety to relevant stakeholders, including Genmab employees, CROs, and Investigators.
- Proactively engage with internal stakeholders, such as multidisciplinary project groups, and external stakeholders, including external experts, partners, and regulatory authorities.
- Take part in audits and inspections.
- Train and mentor teams on emerging safety aspects and PV processes/technologies/regulations.
- MD required.
- Minimum requirement: 5+ years' experience in drug safety/pharmacovigilance covering both clinical development and post-marketing.
- Solid clinical judgment: experience in oncology is a plus.
- Experience with PV audits/Regulatory Authority Inspections and worldwide regulatory authorities' interactions.
- Experience with global PV regulatory environment (regulations, initiatives, standards, GVP); MedDRA and WHODrug coding dictionaries.
- Experienced in individual adverse event case report processing, triage, and medical review.
- Experience with safety databases (ARISg, ARGUS, or other safety database applications) and electronic data capture systems preferred.
- Experience guiding and mentoring team members.
- Proven performance in earlier role/comparable role.
We are looking for a passionate and experienced professional who is committed to our purpose and genuinely cares about our mission to transform the lives of patients through innovative cancer treatment. You bring rigor and excellence to all that you do and are a fierce believer in our rooted-in-science approach to problem-solving. You are a generous collaborator who can work in teams with diverse backgrounds and are determined to do and be your best and take pride in enabling the best work of others on the team.
LocationsGenmab leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories. Whether you're in one of our collaboratively designed office spaces or working remotely, we thrive on connecting with each other to innovate.
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Plainsboro, New Jersey, United States Genmab Full timeAbout the RoleWe are seeking an experienced Associate Director to join our Drug Safety & Pharmacovigilance team at Genmab. As a key member of our global safety strategy team, you will be responsible for ensuring the safe development and marketing of our innovative antibody products.Key ResponsibilitiesLead pre- and post-marketing safety-related activities,...
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Associate Director, Global Drug Safety Expert
2 weeks ago
Plainsboro, New Jersey, United States Genmab Full timeAbout the RoleWe are seeking an experienced Associate Director to join our Drug Safety & Pharmacovigilance team at Genmab. As a key member of our global safety strategy, you will contribute to the development and implementation of safety protocols for our investigational products.Key ResponsibilitiesLead pre- and post-marketing safety-related activities,...
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Associate Director, Global Drug Safety Expert
4 weeks ago
Plainsboro, New Jersey, United States Genmab Full timeJob SummaryWe are seeking an experienced Associate Director, Global Drug Safety to join our team at Genmab. As a key member of our Drug Safety and Pharmacovigilance team, you will be responsible for leading major pre- and post-marketing safety-related activities, including signal identification and assessment, benefit-risk evaluation, and risk management...
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Associate Director, Global Drug Safety Expert
4 weeks ago
Plainsboro, New Jersey, United States Genmab Full timeAbout the RoleGenmab is seeking an experienced Associate Director to join our Global Drug Safety team. As a key member of our team, you will be responsible for leading major pre- and post-marketing safety-related activities, including signal identification and assessment, benefit-risk evaluation, and risk management activities.Key ResponsibilitiesLead all...
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Associate Director, Global Drug Safety Expert
4 weeks ago
Plainsboro, New Jersey, United States Genmab Full timeAbout the RoleWe are seeking an experienced Associate Director to join our Global Drug Safety team at Genmab. As a key member of our team, you will be responsible for leading major pre- and post-marketing safety-related activities, including signal identification and assessment, benefit-risk evaluation, and risk management activities.Key ResponsibilitiesLead...
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Associate Director, Global Drug Safety
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Associate Director, Global Drug Safety Expert
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Associate Director, Global Drug Safety Expert
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Plainsboro, New Jersey, United States Genmab Full timeAbout the RoleWe are seeking an experienced Associate Director to join our Drug Safety and Pharmacovigilance team at Genmab. As a key member of our team, you will be responsible for leading major pre- and post-marketing safety-related activities, including signal identification and assessment, benefit-risk evaluation, and risk management activities.Key...
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Associate Director, Global Drug Safety
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Plainsboro, New Jersey, United States Genmab Full timeJob SummaryGenmab is seeking an experienced Associate Director to join our Drug Safety and Pharmacovigilance team. As a key member of our global safety team, you will be responsible for leading major pre- and post-marketing safety-related activities, including signal identification and assessment, benefit-risk evaluation, and risk management activities.Key...
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Plainsboro, New Jersey, United States Genmab Full timeAbout the RoleWe are seeking an experienced Associate Director to join our Global Drug Safety and Pharmacovigilance team in Princeton. As a key member of our team, you will be responsible for ensuring the safety of our products throughout their lifecycle, from clinical trials to post-marketing surveillance.Key ResponsibilitiesPerform safety reviews of...
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Associate Director, Global Drug Safety
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Plainsboro, New Jersey, United States ZipRecruiter Full timeAbout the RoleWe are seeking a highly skilled and experienced Associate Director, Global Drug Safety to join our team. As a key member of our Global Drug Safety and Pharmacovigilance department, you will be responsible for ensuring the safety of our products throughout the clinical trial and post-marketing environments.Key ResponsibilitiesPerform safety...
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Associate Director, Global Drug Safety
1 month ago
Plainsboro, New Jersey, United States Genmab Full timeJob OverviewAt Genmab, we're committed to pushing the boundaries of innovation in cancer treatment and serious diseases. As an Associate Director, Global Drug Safety, you'll play a critical role in shaping our global safety strategy and ensuring the highest standards of product safety.The Drug Safety & Pharmacovigilance (GDS&PV) Physician role is a key...
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Plainsboro, New Jersey, United States Genmab Full timeJob SummaryWe are seeking an experienced Associate Director of Global Drug Safety and Pharmacovigilance to join our team at Genmab. As a key member of our Global Drug Safety and Pharmacovigilance department, you will be responsible for ensuring the safe and effective development and marketing of our products.Key ResponsibilitiesPerform safety review of...
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Director of Global Drug Safety
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Plainsboro, New Jersey, United States Genmab Full timeJob SummaryWe are seeking an experienced Associate Director, Global Drug Safety and Pharmacovigilance to join our team at Genmab. As a key member of our Global Drug Safety and Pharmacovigilance department, you will be responsible for ensuring the safe and effective development of our products.Key ResponsibilitiesPerform safety reviews of adverse event...
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Plainsboro, New Jersey, United States Genmab Full timeAbout the RoleWe are seeking a highly skilled and experienced Senior 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 our global safety strategy and ensuring the overall safety profile of our assigned products throughout their lifecycle.Key...
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Plainsboro, New Jersey, United States Genmab Full timeJob SummaryWe are seeking a highly skilled and experienced Associate Director, Global Drug Safety and Pharmacovigilance Lead to join our team at Genmab. As a key member of our Global Drug Safety and Pharmacovigilance department, you will be responsible for leading the development and implementation of safety strategies for our products.Key...
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Plainsboro, New Jersey, United States Genmab Full timeAbout the RoleGenmab is seeking an experienced Associate Director of Global Safety and Pharmacovigilance to join our team. As a key member of our Drug Safety and Pharmacovigilance (GDS&PV) team, you will play a critical role in ensuring the safety of our products throughout their lifecycle.Key ResponsibilitiesLead Safety-Related Activities: You will lead all...
