- Socks-Off (KYSO) antibody medicines.
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VP, Patient Safety and Pharmacovigilance
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SME - PHARMA Safety/ Pharmacovigilance
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The Dignify Solutions LLC Raritan, United StatesResponsibilities: · 1.Will be responsible for building and driving business transformation capabilities across Pharmacovigilance and pharma R&D benefit management value chain with market research · 2. Should be able to create roadmap, TCO, ROI model, blueprints, implementation ...
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Pharma People Princeton, United StatesOur client is a leading High Growth Biotech looking to expand their PV team bringing on an Associate Director/Director, Drug Safety and Pharmacovigilance Physician to serves as a critical medical and data analytical expert for the assigned investigational. The overall goal for th ...
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Otsuka Pharmaceutical Co., Ltd. Princeton, United StatesPosition Summary · Leads product safety teams in all aspects of pharmacovigilance and risk management activities for assigned products both marketed and in development. Key activities include medical analysis and decision making for the development and maintenance of the Company ...
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Vp, Patient Safety and Pharmacovigilance
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Genmab Kingston, United StatesAt Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, ca ...
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GPV Case Management Product Specialist
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GForce Life Sciences Trenton, United StatesSummary · Our growing, mid-sized pharmaceutical client has engaged GForce Life Sciences to provide a GPV Submission Specialist responsible for managing daily operational activities of the Global Submissions Team within Case processing. · Description · Monitor and manage the ICSR ...
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Chief Medical Officer
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Director, Statistical Programming
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Daiichi Sankyo Trenton, United StatesDirector, Statistical Programming · in · Basking Ridge · at · Daiichi Sankyo · Join a Legacy of Innovation 110 Years and Counting · Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address d ...
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Manager, Regulatory Affairs
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Director, Statistical Programming
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Daiichi Sankyo Trenton, United StatesDirector, Statistical Programming · in · Basking Ridge · at · Daiichi Sankyo · Join a Legacy of Innovation 110 Years and Counting · Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address d ...
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Director, Statistical Programming
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Daiichi Sankyo Company, Limited Trenton, United StatesDirector, Statistical Programming page is loaded · Director, Statistical Programming · Apply · remote type · Hybrid Work Arrangement · locations · Basking Ridge, NJ · time type · Full time · posted on · Posted 3 Days Ago · job requisition id · R2943 · Join a Legacy o ...
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Director, Global Drug Safety
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Director, Safety Scientist Early Development
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Clinical Trial Coordinator
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Drug Safety Systems Analyst
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Safety Systems Analyst II
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Safety Case Management Product Specialist
2 weeks ago
GForce Life Sciences Princeton, United StatesConsultant, GPV Case Management Product Specialist, Pharmaceuticals · Summary · Our growing, mid-sized pharmaceutical client has engaged GForce Life Sciences to provide a GPV Submission Specialist responsible for managing daily operational activities of the Global Submissions Tea ...
Associate Digital Product Manager, Global Drug Safety and Pharmacovigilance - Trenton, United States - Genmab
Description
At Genmab, were committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases.
From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose.
Associate Digital Product Manager, Global Drug Safety and Pharmacovigilance This person will be based out of Princeton, NJ and will be onsite 60% of the time.
Genmab is driving the next generation of innovative and differentiated antibody-based medicines to transform the lives of patients with cancer and other serious diseases.
Were transforming the treatment landscape for patients with cancer and other serious diseases by combining deep antibody expertise with unique methods of scientific discovery.
We focus exclusively on antibodies, putting our deep understanding of disease biology and treatment targets to work using innovative antibody technology platforms.
The Opportunity:
At Genmab, AI and Digital Technologies are being developed, implemented, and utilized at a pace never seen before.
Join Genmab as part of our IT & Digital Team and become a key player in revolutionizing antibody-based medicines for cancer and serious diseases.
We're at the forefront of merging deep antibody expertise with groundbreaking scientific discovery, focused on transforming patient care.Dive into the dynamic world of AI and Digital Technologies at Genmab The Role:
As an Associate Digital Product Manager in IT & Digital, you will have a critical role in overseeing the product strategy, development/implementation and management of technology products in different focus areas in Global Drug Safety and Pharmacovigilance.
These digital products are crucial to enable Business to operate and efficiently manage our growing drug development and marketed drugs portfolio.
Ideally, you are an expert with excellent domain knowledge in above areas, coupled with robust experience in digital product management and delivery.
In this role, you will collaborate closely with Business to help define product vision and roadmaps based on business requirements and user needs.
You will standup and lead agile Product Oriented Delivery (POD) team(s) and be accountable for successful delivery and ongoing product evolution and operational support.
Your responsibility also includes defining and monitoring measurable Objectives and Key Results (OKRs) and Key Performance Indicators (KPIs), ensuring alignment with our strategic goals.
Responsibilities:
Using the Product Oriented Delivery (POD) model, ensure its success and application in the development/implementation and utilization of technology products across the value chain of Global Drug Safety and Pharmacovigilance Be accountable for full life cycle of products in your portfolio from concept to retirement.
Product suite may include SaaS products as well as in-house custom digital products. Collaborate with Business and IT&D stakeholders and SMEs to define product vision and roadmap aligning with organizational goals.Build required business cases and value propositions and align with stakeholders and leadership team Drive the design, development/implementation, testing, deployment and ongoing product evolution and SLA-based operational support of high-quality products, implementing agile and DevOps methodologies for efficient delivery.
If product requires computer system validation, be accountable for the initial GxP implementation as well as revalidation/ongoing deliverables needed to maintain GxP compliance beyond initial release Provide technical guidance and mentorship within the team, promoting a culture of collaboration, innovation, agility and continuous improvement.
Contribute to budget planning and allocation of resources for both product development and ongoing operational support.Track and report on product performance, addressing any issues affecting quality or user satisfaction, and optimize processes for improved efficiency.
Act as the users representative and voice of customer in POD discussions.Collaborate with broader IT team as needed for successful road-mapping, delivery and support Manage multiple use cases/ products simultaneously, establishing processes for intake, assessment, and decision-making.
Coordinate with other Product Owners across Research and Development to manage dependencies.Requirements:
Bachelor's degree in Computer Science, Engineering, Lifesciences. MBA or Masters degree in strategy, management, engineering or a related field preferred.
In-depth knowledge of Agile Software Development Methodology and related tools like Jira 8 years of experience as a product owner, product manager, senior business analyst in Global Drug Safety and Pharmacovigilance areas, with at least 3 years in a delivery leadership role.
Product Lead, or similar, role in SaaS GxP implementations and/or bespoke GxP digital products in a mid-sized biopharma or CRO Experience working with GxP regulations and procedures around change management, periodic reviews, and internal audits.
Knowledge of the ITIL framework and SLA-based environment.Experience leading RFI/RFP processes for market scan, vendor evaluation and selection, in collaboration with Business and IT stakeholders and other crossfunctional teams Ability to effectively interpret a business problem into a technical solution and articulate it back to the business stakeholders.
Solid understanding of regulatory guidelines and data standards is a plus Ability to work with and lead diverse and cross-functional teams Excellent communication, negotiation and interpersonal skills, with the ability to engage and influence stakeholders at all levels.
Strong problem-solving skills and the ability to work in a fast-paced, dynamic environment. Why Genmab? Be part of a multicultural, innovative environment where your work directly impacts cancer patients' lives. Our unique culture fosters experimentation, empowerment, and growth. We value teamwork, diversity, and an inclusive, supportive work environment. At Genmab, diversity drives our success. We ensure a professional, inclusive environment, valuing different perspectives and experiences.Ready to make a real difference in transforming patient care? Apply now to be part of Genmab's journey in advancing innovative healthcare solutions For US based candidates, the proposed salary band for this position is as follows:
$114,375.00$190,625.00The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as bonuses. About You You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment You bring rigor and excellence to all that you do. You 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 You are determined to do and be your best and take pride in enabling the best work of others on the team You are not afraid to grapple with the unknown and be innovative You have experience working in a fast-growing, dynamic company (or a strong desire to) You work hard and are not afraid to have a little fun while you do so Locations Genmab 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 youre in one of our collaboratively designed office spaces or working remotely, we thrive on connecting with each other to innovate. About Genmab Genmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. For more than 20 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates. To help develop and deliver novel antibody therapies to patients, Genmab has formed 20 strategic partnerships with biotechnology and pharmaceutical companies. By 2030, Genmabs vision is to transform the lives of people with cancer and other serious diseases with Knock-Your
