Associate Director, Global Drug Safety and Pharmacovigilance Scientist

Genmab US, Inc.

Plainsboro, NJFull-time$223–244K/yrTracked 4w agoSeen in employer's feed 4 days ago

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At a glance

Compensation

$223–244K/yr

Location

Plainsboro, NJ

Schedule

Full-time

Work Authorization

Not specified

Requirements

Credentials this posting asks for.

Bachelor's degree

Job overview

Genmab US, Inc. is hiring an Associate Director, Global Drug Safety and Pharmacovigilance Scientist. The Associate Director, Global Drug Safety and Pharmacovigilance Scientist will perform safety reviews of Adverse Event reports for Genmab products, supporting complex oncology development programs from first-in-human through post-marketing. This role involves providing strategic safety input for protocol amendments, risk mitigation strategies, and study design decisions. The scientist will also contribute to regulatory interactions, lead safety strategy documentation, and ensure compliance with regulatory guidelines and internal processes.

Key focus areas include Perform safety review of Adverse Event reports for Genmab products, Support high-priority, complex oncology development programs, and Provide strategic safety input for protocol amendments, risk mitigation strategies, and study design decisions.

Successful candidates bring 7 Years Drug Safety And Pharmacovigilance Experience, Bachelor's Degree In Pharmacy, Chemistry, Or Related Natural Sciences Field, and 7 Years Experience With First Human Trials. Important skills include Safety Review Of Adverse Event Reports, Strategic Safety Input, Risk Mitigation Strategies, Study Design Decisions, Safety Signal Detection, and Clinical Holds.

Skills & qualifications

RequiredNice to have

Skills

Safety Review of Adverse Event ReportsStrategic Safety InputRisk Mitigation StrategiesStudy Design DecisionsSafety Signal DetectionClinical HoldsRegulatory QuestionsSafety StrategyDocumentation for Regulatory SubmissionsIntegrated Safety Analyses PresentationExpert Safety GuidanceSponsor Oversight of Global CROsQuality Assurance of Safety DeliverablesTimeliness of Safety DeliverablesRegulatory Compliance of Safety DeliverablesSignal EvaluationSafety Data SurveillanceTrial Protocols ReviewECRFs/CRFs ReviewTMFs ReviewInvestigator's Brochures DevelopmentSubject Informed Consent DevelopmentHA RequestsKey Submission Documents ReviewSafety Assessment ReportsRSI in IBADR in CCDSProduct LabelsAggregate Safety ReportsRMPSafety Committee Activities PlanningDMC's ConductSafety TrainingNew Tools DevelopmentProcess OptimizationSafety Data Exchange Agreements ReviewRegulatory Guidelines SurveillanceImpact Assessment on Drug Safety ProcessesInternal Processes and Procedures ComplianceAudit and Inspection PreparationAudit and Inspection Activities ParticipationArgus Safety Database

Qualifications

Bachelor's DegreeBachelor's in Pharmacy, Chemistry, or Related Natural Sciences Field7 Years Drug Safety and Pharmacovigilance Experience in Pharmaceutical Industry7 Years Experience With First Human Trials7 Years Experience Overseeing Multiple Trials With Safety Inputs at Global Level7 Years Experience Collaborating With Cross-Functional Teams7 Years Experience Performing Ongoing Surveillance of Safety Data7 Years Experience Ensuring Compliance With Regulatory Guidelines7 Years Experience With International Stakeholders

Benefits

401(k) Match

Medical Insurance

Dental Insurance

Vision Insurance

Paid Time Off

Parental Leave

Tuition Assistance

Full job description

Experience Required

7 years

Minimum Education Required

Bachelor's degree

Compensation

$223,142.00 - $243,960.00 / Yearly

Hours Per Week

Number Of Positions

Shift

First Shift (Day)

Job Description

Genmab seeks a Associate Director, Global Drug Safety and Pharmacovigilance Scientist in Plainsboro, NJ.

POSITION DUTIES: The Associate Director, Global Drug Safety and Pharmacovigilance Scientist will be responsible for performing safety review of Adverse Event reports for Genmab products. Supporting high-priority, complex oncology development programs, including fast-tracked and pivotal programs such as Rinatabart sesutecan (Rina-S / GEN1184), from first-in-human through late-stage development and post-marketing. Providing strategic safety input for protocol amendments, risk mitigation strategies, and study design decisions based on emerging safety data from pivotal and registrational studies. Supporting Health Authority interactions related to safety signals, clinical holds, risk mitigation measures, and responses to regulatory questions for advanced-stage oncology programs. Leading or significantly contributing to safety strategy and documentation supporting pivotal development milestones and regulatory submissions. Playing an active role in cross-functional safety governance forums (e.g., Safety Committees, Risk Management Working Groups), including preparation and presentation of integrated safety analyses for senior stakeholders. Representing Global Drug Safety as a core member of Clinical Management Teams (CMTs) for complex oncology programs, providing expert safety guidance to clinical, regulatory, and operational stakeholders. Providing sponsor oversight of global CROs supporting pivotal oncology studies, ensuring quality, timeliness, and regulatory compliance of safety deliverables. Performing ongoing surveillance (including signal detection/evaluation) of Genmab clinical trials and post marketing safety data. Providing safety review and input to various documents including, but not limited to: Trial Protocols, eCRFs/CRFs, and TMFs as well as contributing to the development of other documentation such as Investigator’s Brochures, and Subject Informed Consent. Contributing to HA requests and reviewing key submission documents. Contributing to safety-related documents for Genmab products throughout the product lifecycle from FIH to post-marketing, including monthly safety surveillance, Safety Assessment Reports for potential signals/risks, RSI in IB, ADR in the CCDS and product labels, Aggregate Safety Reports (e.g. DSUR, PBRER, PSUR, PAER), RMP, and responses to ad-hoc requests for safety information internally and externally. Contributing to the planning and conduct of Safety Committee activities and DMC’s. Conducting safety training of Genmab employees, CROs, Investigators and other relevant site personnel as necessary. Contributing to multidisciplinary project groups including membership of the Clinical Management Team (CMT) for assigned products. Contributing to the development and optimization of new tools and processes. Interacting with safety and clinical CROs, performing sponsor oversight activities for safety related tasks, process invoices, and ensuring regulatory compliance (including regulatory reporting requirements) for assigned products. Supporting review of Safety Data Exchange Agreements with partners as required. Performing ongoing surveillance of new and updated regulations/guidelines and assessing the impact on drug safety processes at Genmab. Ensuring compliance with regulatory guidelines and internal processes and procedures in preparation of audits and inspections. Participating in audit and inspection activities as required. Annual salary between $223,142-$243,960.

POSITION REQUIREMENTS: Requires a Bachelor’s degree (or foreign equivalent) in Pharmacy, Chemistry, or a related natural sciences field plus at least 7 years (84 months) of experience with drug safety and pharmacovigilance in the pharmaceutical industry for products in clinical trial and post marketing environments. Must possess at least 7 years (84 months) of progressive post-baccalaureate experience with all of the following: (a) first human trials; (b) overseeing multiple trials with safety inputs at the global level; (c) collaborating with cross-functional teams to continuously improve the efficiency of quality control processes, contributing to audit readiness and ensuring alignment with both client expectations and regulatory requirements; (d) performing ongoing surveillance (including signal detection and evaluation) of safety data; (e) ensuring compliance with regulatory guidelines and internal processes and procedures in order to be prepared for audits and inspections; (f) international experience with internal and external stakeholders; and (g) Argus Safety Database. Experience may be gained concurrently. Position may allow working from home within commuting distance of worksite location.

Benefits: Within the first year, regular full-time U.S. employees are eligible for:

401(k) Plan: 100% match on the first 6% of contributions
Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance
Voluntary Plans: Critical illness, accident, and hospital indemnity insurance
Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave
Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being support
Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expense