Associate Director, Global Drug Safety & Pharmacovigilance Physician

At Genmab we are dedicated to building extranotordinary futures together by developing antibody products and groundbreaking knock-your-socks-off KYSO antibody medicines that change lives and the future of cancer treatment and serious diseases. We strive to create champion and maintain a global workplace where individuals unique contributions are valued and drive innovative solutions to meet the needs of our patients care partners families and employees.

Our people are compassionate candid and purposeful and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes our work is incredibly serious and impactful but we have big ambitions bring a ton of care to pursuing them and have a lot of fun while doing so.

Does this inspire you and feel like a fit Then we would love to have you join us!

Genmab US Inc.

Associate Director Global Drug Safety & Pharmacovigilance Physician

Location: Plainsboro NJ

Job Description

Serve as the safety expert accountable for the global safety strategy and overall safety profile for assigned Genmab products (investigational) throughout their lifecycle including leading all major pre- and post-marketing safety related deliverables including signal benefit-risk evaluation and risk management activities. Interface cross-functionally at all levels in the organization as well as with external Regulatory Authorities. Work together with other Drug Safety (DS) staff in managing the safety assessment of products including review of individual and aggregate AEs and the scientific literature preparing safety reports and communicating changes in the product risk profile to internal and external stakeholders. Perform medical review of Adverse Events reports for Genmab products. Perform ongoing surveillance of safety data for Genmab products from different sources. Ensure handling of safety issues and implementing risk mitigation activities. Perform medical review and provide input to different documents e.g. Trial Protocols and amendments Clinical Trial Reports Trial plans eCRFs/CRFs TMFs Investigators Brochures Subject Informed Consent Development Safety Update Reports Integrated Safety Summaries scientific articles etc. Prepare benefit/risk sections of aggregate reports and safety summaries in accordance with regulatory requirements for assigned compounds. Responsible for establishment and management of external Data monitoring Committees (DMCs). Position allows working from home within commuting distance of worksite location. Annual salary between: $227490-$280320.

Job Requirements

The qualified candidate must have a Doctor of Medicine degree or foreign equivalent degree. The qualified candidate must have at least 10 years (120 months) of Drug Safety/Pharmacovigilance and clinical development experience. The qualified candidate must have at least 10 years (120 months) of experience with all of the following: (a) global PV regulatory environment with working knowledge of international regulations initiatives standards and Good Pharmacovigilance practices (GVP); (b) working with the FDA and other regulatory authorities; (c) individual adverse event case report processing triage and medical review; (d) safety databases (ARISg ARGUS or other safety database applications) and electronic data capture systems; (e) MedDRA and MedDRA and WHODrug coding dictionaries; (f) PV audit process with active participation in Regulatory Authority Inspections; (g) drug development process; (h) utilizing the following technologies: Microsoft Excel PowerPoint and Word. Position allows working from home within commuting distance of worksite location. All experience may be gained concurrently.

#LI-DNI

For US based candidates the proposed salary band for this position is as follows:

The actual salary offer will carefully consider a wide range of factors including your skills qualifications experience and location. Also certain positions are eligible for additional forms of compensation such as discretionary bonuses and long-term incentives.

When you join Genmab youre joining a culture that supports your physical financial social and emotional wellness. 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 expenses

About You

• You are genuinely passionate about our purpose

• You bring precision and excellence to all that you do

• You believe in our rooted-in-science approach to problem-solving

• You are a generous collaborator who can work in teams with a broad spectrum of backgrounds

• You take pride in enabling the best work of others on the team

• You can 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!

Locations

Genmab maximizes the efficiency of an agile working environment when possible for the betterment of employee work-life balance. Our offices are crafted as open community-based spaces that work to connect employees while being immersed in our powerful laboratories. Whether youre in one of our office spaces or working remotely we thrive on connecting with each other to innovate.

About Genmab

Genmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years its hard-working innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational quantitative and data sciences resulting in a proprietary pipeline including bispecific T-cell engagers antibody-drug conjugates next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030 Genmabs vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO) antibody medicines.

Established in 1999 Genmab is headquartered in Copenhagen Denmark with international presence across North America Europe and Asia Pacific. For more information please visit and follow us on LinkedIn and X.

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 Job Applicant Privacy Notice ().

Please note that if you are applying for a position in the Netherlands Genmabs policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year if the employee performs well and if the business conditions do not change renewal for an indefinite term may be considered after the fixed-term employment contract.