Associate Director, Drug Safety & Pharmacovigilance – Hybrid

Genmab A/S; Princeton (NJ); Hybrid; USD 162,640 - 243,960; Full time

Benefits offered by this job

401(k) Plan: 100% match on first 6% of contributions

Two medical plan options including HDHP with HSA

Paid vacation, sick leave, holidays

Discretionary paid parental leave

Commuter benefits, tuition reimbursement

Job summary

Genmab A/S is looking for an Associate Director of Drug Safety and Pharmacovigilance in Princeton, NJ. The role involves developing safety strategies, overseeing safety activities with CROs, and authoring essential safety documents. Applicants should have a healthcare degree with over 5 years in drug safety and experience with FDA/EMA regulations. The position offers competitive pay between $162,640.00 and $243,960.00 and hybrid work arrangements. Additional benefits include health insurance and a matching 401(k) plan.

Qualifications

• ≥5 years of pharmaceutical industry experience in drug safety & pharmacovigilance.
• Experience authoring safety signal assessment reports, DSUR, PBRER, RMP, and RSI.
• International experience managing internal and external stakeholders.

Responsibilities

• Contribute to the development of safety strategy and deliverables.
• Perform ongoing surveillance of clinical trials and post-marketing safety data.
• Deliver safety training to employees, CROs, and investigators.

Skills

Signal detection processes

Communication skills

Proactive prioritization

Oncology experience

Regulatory compliance

Education

Health Care Professional degree (RN/BSN/MSN, NP, PA, PharmD)

Tools

Argus safety database

Job description

Genmab A/S is looking for an Associate Director of Drug Safety and Pharmacovigilance in Princeton, NJ. The role involves developing safety strategies, overseeing safety activities with CROs, and authoring essential safety documents. Applicants should have a healthcare degree with over 5 years in drug safety and experience with FDA/EMA regulations. The position offers competitive pay between $162,640.00 and $243,960.00 and hybrid work arrangements. Additional benefits include health insurance and a matching 401(k) plan.