ADC Therapeutics America Inc
Director, Pharmacovigilance Scientist
ADC Therapeutics America Inc, New Providence, New Jersey, us, 07974
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.
Who You Are:
Bachelor’s in sciences/pharmacy/nursing degree or related field Bachelor’s degree in health-care related discipline or equivalent.
RN, R.Ph., or Pharm D. degree is highly preferred.
8+ years of proven pharmacovigilance experience, preferably in oncology.
Patient Safety and/or Clinical/Drug Development with proven experience working in safety &/or scientific activities in at least 3 of the following areas:
Clinical drug development (Early and/or Late Phase: develop & deliver program level safety strategy, including proactive risk identification & mitigation planning).
Post-Marketing Surveillance (including signal detection & evaluation).
MAA/BLA (preparation and authoring of the safety related aspects of the Common Technical Document).
Periodic Safety Reports (deliver strategy, preparation and authoring).
Risk Management Plans (deliver strategy, preparation and authoring).
Safety governance board interactions and communication across a range of activities.
Demonstrated ability to handle more than one activity simultaneously, prioritizing and recognizing key issues.
Ability to work effectively in an advanced matrix structure.
Proficient in expressive and receptive communications in English language.
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 in multiple trials with safety inputs at the Global level.
International experience from a similar role with internal and external stakeholders.
Participate in audit preparedness activities and serves as subject matter expert during regulatory inspections in collaboration with team members.
Expert level proficiency in reporting and data analysis tools, including Excel.
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.
#J-18808-Ljbffr
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.
Who You Are:
Bachelor’s in sciences/pharmacy/nursing degree or related field Bachelor’s degree in health-care related discipline or equivalent.
RN, R.Ph., or Pharm D. degree is highly preferred.
8+ years of proven pharmacovigilance experience, preferably in oncology.
Patient Safety and/or Clinical/Drug Development with proven experience working in safety &/or scientific activities in at least 3 of the following areas:
Clinical drug development (Early and/or Late Phase: develop & deliver program level safety strategy, including proactive risk identification & mitigation planning).
Post-Marketing Surveillance (including signal detection & evaluation).
MAA/BLA (preparation and authoring of the safety related aspects of the Common Technical Document).
Periodic Safety Reports (deliver strategy, preparation and authoring).
Risk Management Plans (deliver strategy, preparation and authoring).
Safety governance board interactions and communication across a range of activities.
Demonstrated ability to handle more than one activity simultaneously, prioritizing and recognizing key issues.
Ability to work effectively in an advanced matrix structure.
Proficient in expressive and receptive communications in English language.
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 in multiple trials with safety inputs at the Global level.
International experience from a similar role with internal and external stakeholders.
Participate in audit preparedness activities and serves as subject matter expert during regulatory inspections in collaboration with team members.
Expert level proficiency in reporting and data analysis tools, including Excel.
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.
#J-18808-Ljbffr