Associate Director, Global Drug Safety & Pharmacovigilance

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!

Associate Director Global Drug Safety & Pharmacovigilance Scientist

Genmab is an international biotechnology company specializing in the invention and development of differentiated human antibody therapeutics for the treatment of cancer and other important human diseases.

Role

Genmab is on an ambitious growth path and to support this growth Genmab is looking for an additional Global Drug Safety (DS) and Pharmacovigilance (PV) Scientist to join the team in Princeton.

As an Associate Director of Drug Safety and Pharmacovigilance you will become part of the Global Drug Safety and Pharmacovigilance department where you will be responsible for drug related activities in close cooperation with Safety colleagues along with cross-functional team members. This position has a global perspective and you will interact with stakeholders ranging from regulatory authorities and colleagues from Genmabs four sites.

As an Associate Director of Drug Safety and Pharmacovigilance you will be part of a highly skilled and international team. The position reports to the Director Global Drug Safety & Pharmacovigilance Scientist Lead.

Responsibilities

• Perform safety review of Adverse Event reports for Genmab products
• Perform ongoing surveillance (including signal detection/evaluation) of Genmab clinical trials and post marketing safety data
• Be the primary safety contact for other departments and ensure appropriate and timely handling of safety issues
• Provide safety review and input to various documents including but not limited to: Trial Protocols eCRFs/CRFs and TMFs
• You will also be contributing to the development ofother documentation such as: Investigators Brochures and Subject Informed Consent
• Contribute to HA requests and review key submission documents
• Contribute to safety-related documents for Genmab products throughout 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
• Contribute to the planning and conduct of Safety Committee activities and DMCs
• Conduct safety training of Genmab employees CROs Investigators and other relevant site personnel as necessary
• Contribute to multidisciplinary project groups including membership of the Clinical Management Team (CMT) for assigned products
• Contribute to the development and optimization of new tools and process

• Contribute to multidisciplinary project groups including membership of the Clinical Management Team (CMT) for assigned products
  • Interact with safety and clinical CROs perform sponsor oversight activities for safety related tasks process invoices and ensure regulatory compliance (including regulatory reporting requirements) for assigned products
  • Support review of Safety Data Exchange Agreements with partners as required
  • Collaborate with external experts and partners
  • Perform ongoing surveillance of new and updated regulations/guidelines and assess the impact on drug safety processes at Genmab
  • Ensure compliance with regulatory guidelines and internal processes and procedures in preparation of audits and inspections
  • Participate in audit and inspection activities as required
  • Other duties as assigned

Requirements

• Health Care Professional degree required (e.g. RN/BSN/MSN NP PA PharmD) and 5 years of pharmaceutical industry experience in drug safety & pharmacovigilance as a Safety Scientist for products in the clinical trial and post-marketing environments
• Experience within the field of oncology is preferred and/or immunology
• Experience authoring safety signal assessment report DSUR PBRER RMP and RSI
• Skilled in signal detection process and managing safety information from clinical development and post-marketing sources
• Experienced with FDA/EMA regulations and ICH guidance governing pharmacovigilance and risk management
• Knowledge of drug development process pharmacovigilance databases and MedDRA coding
• Experience with use of safety databases preferably Argus Safety Database
• Documented experience from overseeing multiple trials with safety inputs at the Global level
• International experience from a similar role with internal and external stakeholders
• Excellent communication skills in English both written and spoken

Moreover you meet the following personal requirements:

• Strong communicator and good at building professional relations with collaborators and business partners.
• You are proactive and able to prioritize work in a fast paced and changing environment
• You are result-and goal-oriented and committed to contributing to the overall success of Genmab

Other

Genmab employees work with determination and with respect for each other consistent with our core values to achieve our common goals. We give individuals and teams the autonomy to drive development of innovative products and solutions knowing that integrity is a core value throughout our company. Genmab will offer the successful application a challenging position where the right candidate will have the opportunity to work with highly specialized people across functions in an informal multicultural culture all aiming to make a difference for cancer patients.

Teamwork and respect are central pillars of Genmabs culture and we therefore ensure an inclusive open and supportive professional work environment across our international locations. We believe that fostering workplace diversity across social educational cultural national age and gender lines is a prerequisite for the continued success of the company. We are committed to diversity at all levels of the company and strive to recruit employees with the right skills and competences regardless of gender age ethnicity etc.

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.