- Oversee and maintain
- safety trial documentation in close collaboration with the GDS&PV associates and safety scientists
- sponsor oversight and spot-checks in the electronic Trial Master File (e-TMF of safety documentation in collaboration with safety scientists
- quality check of filing Safety (Operational) Management Plans
- proper indexing and maintenance of key inputs, adhering to naming convention in the e-TMF
- Ensure the proper eTMF numbering of uploaded safety documents are listed in overviews
- Upload and retrieve safety documents to/from Veeva Vault (eTMF- and Quality module)
- Assist with documentation preparation for inspections and audits.
- Maintain Department SharePoint site(s)
- Monitoring and assign tasks in shared mailbox(es)
- Back-up the Associates within the team and cover during vacation time and out-of-office on general business support but not limited to;
- Support with Training Assignments for GDS&PV Department dossier in Veeva
- GCP training compliance and documentation
- Distribution of GxP Procedures (internal as well as external)
- Coordinate and present agenda and slides on departmental meetings, compliance team meetings
- Request and keep oversight of Veeva Vault access for safety vendors
- Create and manage shared mailboxes
- Guide and support with record retention of essential documents for GDS&PV
- Relevant experience in Drug Safety, Pharmacovigilance, or Clinical Operations
- Understanding of Good Documentation Practice (GDP) and inspection readiness within the pharmaceutical industry.
- Basic knowledge of various IT systems supporting documentation.
- Experience with compliance, including handling deviations and CAPAs in a safety/clinical setting, preferably with Veeva Vault (eTMF- and Quality module).
- Ability to take initiative and work independently in a dynamic environment while maintaining a positive, team-oriented attitude.
- 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
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Contractor - Global Drug Safety & PV Compliance Associate - Princeton, United States - Genmab
Description
At 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, 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.
We are seeking a dedicated and detail-oriented Associate to provide essential support to our Compliance Team within the Global Drug Safety and Pharmacovigilance (GDS&PV) Department. The ideal candidate will possess a methodical approach to task prioritization, particularly when handling multiple assignments, and exhibit a collaborative and engaging personality.
Key Responsibilities:
Provide comprehensive support in filing and retrieval of trial documentation and oversight on a daily basis as well as prior to, during and after audits and inspections
Qualifications:
We invite enthusiastic and detail-oriented professionals to apply for this opportunity to contribute to our mission of ensuring drug safety and efficacy in a global environment where we work as One Team and your close colleagues are based in US, Japan, and Europe.
About You
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 you're in one of our collaboratively designed office spaces or working remotely, we thrive on connecting with each other to innovate.
About Genmab
Founded in 1999 in Copenhagen, Denmark, Genmab is an innovative biotech company that has become a leader in antibody biology and innovation. Our product pipeline and next-generation antibody technologies are the result of our strong company culture, a deep passion for innovation, and desire to transform cancer treatment and serious diseases.
When you work with us, you'll be part of a warm, fun, dynamic community, and team up with some of the best, most authentic individuals in locations around the world, who care deeply and share in a relentless drive to innovate and create transformational medicines. People who are candid, impact-driven, and a little unconventional; who seek out and embrace the opportunity to build new and bold futures within a rapidly growing and innovative biotech company; who bring their full selves to work and show up for each other - rolling up their sleeves to get the job done. This translates into a place where you can be authentically you; are empowered to innovate, build solutions, and execute; feel cared for and supported in growth; and are a critical part of changing the lives of patients around the world through transformative cancer treatment.
Our commitment to diversity, equity, and inclusion
We are committed to fostering workplace diversity at all levels of the company and we believe it is essential for our continued success. No applicant shall be discriminated against or treated unfairly because of their race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, or genetic information. Learn more about our commitments on our website.
Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website
