Contractor - Global Drug Safety & Pv Compliance Associate

0-5 years

Not Disclosed

Princeton Junction

12 June 11, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Opportunity: Compliance Team Associate at Genmab

Location: Multiple Locations (US, Japan, Europe) with Agile Working Environment

About Genmab: Founded in 1999 in Copenhagen, Denmark, Genmab is a leading biotech company specializing in antibody biology and innovation. Our mission is to develop pioneering therapies that transform cancer treatment and tackle serious diseases. Our collaborative and innovative culture drives our success and makes Genmab a dynamic place to work.

Position: Associate, Compliance Team (Global Drug Safety and Pharmacovigilance - GDS&PV Department)

Job Description: We are seeking a dedicated and detail-oriented Associate to support our Compliance Team within the Global Drug Safety and Pharmacovigilance (GDS&PV) Department. The ideal candidate will be methodical in task prioritization, especially when handling multiple assignments, and possess a collaborative and engaging personality.

Key Responsibilities:

Documentation Management:
- Provide comprehensive support in filing and retrieving trial documentation.
- Oversee and maintain safety trial documentation.
- Ensure proper eTMF numbering of safety documents and maintain proper indexing.
- Upload and retrieve safety documents using Veeva Vault (eTMF- and Quality module).
- Quality check of Safety (Operational) Management Plans.
Audit and Inspection Preparation:
- Assist with documentation preparation for inspections and audits.
- Perform sponsor oversight and spot-checks in the e-TMF.
- Support during audits and inspections.
Administrative Support:
- Maintain department SharePoint site(s).
- Monitor and assign tasks in shared mailbox(es).
- Backup support for Associates within the team during absences.
- Coordinate and present agendas and slides for departmental and compliance team meetings.
Training and Compliance:
- Support with Training Assignments for GDS&PV Department in Veeva.
- Ensure GCP training compliance and documentation.
- Distribute GxP Procedures internally and externally.
Vendor and Record Management:
- Request and maintain oversight of Veeva Vault access for safety vendors.
- Guide and support record retention of essential documents for GDS&PV.

Qualifications:

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, preferably with Veeva Vault (eTMF- and Quality module).
Ability to work independently in a dynamic environment with a positive, team-oriented attitude.

About You:

Passionate about transforming the lives of patients through innovative cancer treatment.
Rigor and excellence in problem-solving with a science-based approach.
Collaborative team player with diverse backgrounds.
Determined to excel and enable the best work of others.
Innovative and unafraid to tackle the unknown.
Experience in a fast-growing, dynamic company or strong desire to gain such experience.
Hard-working and enjoy having fun while working.

Genmab's Culture: At Genmab, we foster a warm, dynamic, and fun community. We value candidness, impact-driven approaches, and a touch of unconventional thinking. Our commitment to diversity, equity, and inclusion ensures that we support our employees' growth and innovation, creating transformational medicines that change patients' lives worldwide.

Commitment to Diversity: Genmab is dedicated to workplace diversity at all levels. We do not discriminate based on race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, or genetic information.

Privacy Policy: Genmab is committed to protecting your personal data and privacy. Please review our privacy policy for information on handling your data in connection with your application: Genmab Privacy Policy.

Apply Now: If you are enthusiastic and detail-oriented, join us at Genmab and contribute to our mission of ensuring drug safety and efficacy in a global environment.

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Contractor - Global Drug Safety & Pv Compliance Associate

Job Description

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