Contractor - Manager, Global Drug Safety & Pv Safety Operations

3+ years

Not Disclosed

Plainsboro

10 Aug. 12, 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, CPC Certified, 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 Title: Drug Safety & Pharmacovigilance Specialist (Contract - 6 Months, Hybrid)

Company Overview

At Genmab, we're dedicated to building extraordinary futures through groundbreaking antibody products and therapies that transform cancer treatment and address serious diseases. Our commitment to innovation is driven by our people—caring, candid, and impact-driven individuals. We believe in being uniquely ourselves, striving for excellence, and staying authentic to achieve our mission.

Role

As a member of our Global Drug Safety & Pharmacovigilance team, you'll focus on safety operations, including the collection and processing of safety information, quality control of safety data, regulatory submissions of individual case safety reports (ICSRs), and case exchanges with business partners.

Key Responsibilities

Quality Control: Perform real-time and retrospective quality control of safety case data entry to ensure compliance with data entry conventions and MedDRA/WHO DD coding standards.
Case Management: Support daily safety case workload management, ensuring compliance with regulatory submissions and internal deadlines. Monitor workflow status and communicate with safety vendors, physicians, and submission stakeholders as needed.
Guidance & Support: Provide guidance on Safety Operations based on company conventions and ICH/regulatory guidance. Ensure accurate reporting destinations and approve regulatory reports in the safety database.
Communication & Documentation: Monitor and triage email communications in Safety Operation Mailboxes. Review and contribute to individual study-specific documents such as Safety Operational Management Plans and SAE Reconciliation Plans.
Reconciliation & Reporting: Perform reconciliation with internal/external stakeholders for case exchanges, analyze reasons for late safety report submissions, and contribute to updating Standard Operating Procedures and training materials.
Project Support: Participate in or support Genmab initiatives and projects related to Safety Operations. Handle other tasks as requested by your supervisor.

Skills and Experience

Experience: Minimum 3 years in drug safety and pharmacovigilance, including case quality control and regulatory submissions of ICSRs.
Education: Bachelor’s or Master’s degree in science.
Knowledge: Understanding of ICH E2B(R2) and (R3) specifications, pharmacovigilance reporting rules and timelines, and ability to interpret medical records.
Technical Skills: Experience with clinical/post-marketing case processing, MedDRA and WHO DD coding, narrative writing, and safety databases (Argus experience is a plus). Familiarity with EDC for clinical trial data collection is an advantage.
Attention to Detail: Excellent skills in detailed-oriented tasks.

About You

Passionate: Driven by our mission to transform patient lives through innovative cancer treatments.
Rigor and Excellence: Committed to delivering excellence and problem-solving with a science-based approach.
Collaborative: A generous team player who thrives in diverse teams.
Innovative: Eager to tackle challenges and embrace innovation.
Dynamic: Experience or strong desire to work in a fast-growing, dynamic environment.
Balanced: Hard-working with a sense of fun and enjoyment in your role.

Locations

Genmab offers a flexible working environment to enhance work-life balance. Our offices are designed to foster community and collaboration while our state-of-the-art laboratories drive innovation. Whether you're working in our offices or remotely, we value connection and collaboration.

About Genmab

Founded in 1999 in Copenhagen, Denmark, Genmab is a leading biotech company specializing in antibody biology and innovation. Our strong company culture, passion for innovation, and commitment to transforming cancer treatment define us. Join a dynamic team where you can be authentically yourself, innovate, and make a difference in patient lives.

Diversity, Equity, and Inclusion

Genmab is committed to diversity and inclusion at all levels. We ensure that all applicants are treated fairly, without discrimination based on race, color, religion, sex, national origin, age, disability, or genetic information. Learn more about our commitments on our website.

For more information about how we protect your personal data, please review our privacy policy at Genmab Privacy Policy.

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