Director, Pharmacovigilance Scientist

Description

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Director, Pharmacovigilance Scientist

New Providence, NJ / Hybrid

Transforming what patients can expect from cancer therapy takes passion and a strong dedicated team. When you join ADC Therapeutics, you will join a group of talented people who share this mission.

Why ADC Therapeutics

ADC Therapeutics (NYSE) : is a commercial, global leader and pioneer in the field of antibody-drug conjugates (ADCs) with a constantly expanding technology toolbox. We are experts in the lifecycle of ADCs – starting with creation all the way through to commercialization. We have a robust pipeline of ADCS in clinical trials for both hematologic and solid tumor cancers. Our CD-19-directed ADC for relapsed / refractory non-Hodgkin lymphoma, ZYNLONTA (loncastuxamab tesirine lpyl) has been approved in the United States and in the European Union. ZYNLONTA is also being evaluated in combination with other anti-cancer therapeutics to determine if it has potential to treat an even broader range of patients.

We consist of nearly 300 dedicated employees, all focused on patient care and driven by purpose who carry out our mission in a flexible work environment. If you’re interested in making a difference in the lives of patients worldwide with a team of like-minded colleagues, come join us on our journey!

To learn more about ADC Therapeutics, please visit us at https : / / adctherapeutics.com / and follow us on LinkedIn.

What You’ll Do : Position Overview

We are looking for a Director, Pharmacovigilance Scientist, to join ADCT in our Global Drug Safety function. In this exciting and challenging role, you will work collaboratively with the Global Safety Physician (GSP), other functions, and vendors who provide PV services. You will play a role supporting the safety strategy and requirements for your assigned drug project(s). Your ability to work collaboratively will facilitate cross-functional interactions with colleagues from across ADCT, including counterparts within Clinical Project Teams, Regulatory Affairs, and Commercial teams.

Main Responsibilities

• Leads PV Scientist activities of cross-functional project teams for developmental compounds and / or marketed products.
• Works in collaboration with the GSP to develop, maintain, oversee, and execute the comprehensive safety surveillance and signal detection plan for assigned products.
• Author and contribute safety sections and other relevant content to Investigator Brochures, Protocols, Informed Consents and Clinical Study Reports.
• Leads the collaboration with GSP and Clinical representatives and authors the Reference Safety Information (RSI) for multiple or complex development products.
• Authors / provides strategic input or oversight for multiple or complex periodic regulatory documents (PBRERs, PSURs, DSURs) according to processes and timelines.
• Authors / provides strategic leadership to regulatory submissions for new products, formulations or indications (NDA / BLA, MAA), in partnership with the GSP and other functional experts.
• Contributes to pharmacovigilance and risk management planning for ADCT products, including preparation of the safety aspects of Risk Management Plans with the applicable License Partners as appropriate and REMS if applicable.
• Supports multidisciplinary SST and SMT and escalation of all relevant safety matters to the appropriate decision-making level, providing appropriate proposals for solutions based on analysis of the available information and in collaboration with the GSP.
• Additional projects as assigned.

Requirements

Who You Are :

ADC Therapeutics is proud to be an Affirmative Action / EEO Employer. EOE Minorities / Females / Protected Veterans / Disabled. We are committed to building diverse teams and fostering an inclusive, professional, and respectful work environment where employees are empowered for success.

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