Associate Director, Global Drug Safety & Pv Scientist

4-11 years

$142,500.00---$237,500.00

Princeton Junction

10 July 4, 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, 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 Description

Job Title: Associate Director of Drug Safety and Pharmacovigilance Scientist
Location: Princeton, NJ
Company: Genmab

Overview

At Genmab, we are committed to building extraordinary futures by developing innovative antibody products and pioneering therapies that transform the lives of patients and the future of cancer treatment and serious diseases. Our people are caring, candid, and impact-driven, and our business is innovative and rooted in science. We value being unique, striving to be our best, and maintaining authenticity to fulfill our purpose.

Genmab is on an ambitious growth path, and to support this, we are seeking an Associate Director of Drug Safety and Pharmacovigilance Scientist to join our team in Princeton. In this role, you will be part of the Global Drug Safety and Pharmacovigilance department, responsible for drug-related activities in close cooperation with Safety colleagues and cross-functional team members. This position has a global perspective and involves interaction with stakeholders, including regulatory authorities and colleagues from Genmab’s four sites. You will report to the Director, Global Drug Safety & Pharmacovigilance, Scientist Lead.

Responsibilities

Perform safety review of Adverse Event reports for Genmab products.
Conduct ongoing surveillance, including signal detection and evaluation, of clinical trials and post-marketing safety data.
Serve as the primary safety contact for other departments and ensure timely handling of safety issues.
Provide safety review and input for various documents, including Trial Protocols, eCRFs/CRFs, and TMFs.
Contribute to the development of Investigator’s Brochures and Subject Informed Consent documents.
Assist with HA requests and review key submission documents.
Develop safety-related documents throughout the product lifecycle, including monthly safety surveillance reports, Safety Assessment Reports, Aggregate Safety Reports (e.g., DSUR, PBRER, PSUR, PAER), RMP, and responses to ad-hoc safety information requests.
Participate in Safety Committee activities and DMCs.
Conduct safety training for Genmab employees, CROs, Investigators, and relevant site personnel.
Contribute to multidisciplinary project groups, including the Clinical Management Team (CMT) for assigned products.
Collaborate with safety and clinical CROs, oversee safety-related tasks, process invoices, and ensure regulatory compliance for assigned products.
Support the review of Safety Data Exchange Agreements with partners.
Collaborate with external experts and partners.
Stay updated on new and revised regulations/guidelines and assess their impact on drug safety processes.
Ensure compliance with regulatory guidelines and internal processes in preparation for audits and inspections.
Participate in audit and inspection activities as needed.
Perform other duties as assigned.

Requirements

Required: Health Care Professional degree (e.g., RN/BSN/MSN, NP, PA, PharmD) and 5+ years of experience in the pharmaceutical industry in drug safety and pharmacovigilance as a Safety Scientist.
Preferred: Experience in oncology and/or first human trials.
Experience authoring safety signal assessment reports, DSURs, PBRERs, RMPs, and RSIs.
Skilled in the signal detection process and managing safety information from clinical development and post-marketing sources.
Familiarity with FDA/EMA regulations and ICH guidelines governing pharmacovigilance and risk management.
Knowledge of drug development processes, pharmacovigilance databases, and MedDRA coding.
Experience with safety databases, preferably Argus Safety Database.
Proven experience overseeing multiple trials with safety inputs at the global level.
International experience with internal and external stakeholders.
Excellent communication skills in English, both written and spoken.

Personal Attributes

Strong communicator with excellent relationship-building skills.
Proactive and able to prioritize work in a fast-paced, changing environment.
Result- and goal-oriented with a commitment to contributing to Genmab’s success.
Determined to do and be your best and take pride in enabling the best work of others.
Not afraid to grapple with the unknown and be innovative.
Experience working in a fast-growing, dynamic company is preferred.

Compensation

Salary Range: $142,500.00 - $237,500.00
The actual salary offer will consider various factors, including skills, qualifications, experience, and location. Certain positions may be eligible for additional forms of compensation, such as bonuses.

About Genmab

Genmab is an international biotechnology company with a core purpose of improving patients' lives through innovative and differentiated antibody therapeutics. Established in 1999, Genmab is headquartered in Copenhagen, Denmark, with locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S., and Tokyo, Japan. Our team is passionate, innovative, and collaborative, leveraging next-generation antibody technology platforms and translational research and data sciences to develop novel therapies. We have formed over 20 strategic partnerships with biotechnology and pharmaceutical companies to help deliver these therapies to patients.

Commitment to Diversity, Equity, and Inclusion

Genmab is dedicated to fostering workplace diversity at all levels of the company, believing it is essential for our continued success. We provide equal employment opportunities to all applicants without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, or genetic information. Learn more about our commitments on our website.

Application Process

To apply, please visit our website and submit your application. Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for details on how we handle your data in connection with your application.

Additional Information for Netherlands-Based Applicants

For permanently budgeted hires in the Netherlands, Genmab’s policy is to initially offer a fixed-term employment contract for a year. If the employee performs well and business conditions remain favorable, renewal for an indefinite term may be considered.

For more information about Genmab and to view our privacy policy, please visit Genmab.

Latest Jobs

Associate Director, Global Drug Safety & Pv Scientist

Job Description

Job Description

Overview

Responsibilities

Requirements

Personal Attributes

Compensation

About Genmab

Commitment to Diversity, Equity, and Inclusion

Application Process

Additional Information for Netherlands-Based Applicants

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