Description: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 that passion.
Company profile
ADC Therapeutics is a rapidly growing commercial-stage biotechnology company listed on the New York Stock Exchange (NYSE) that is improving the lives of cancer patients with its next-generation, targeted antibody drug conjugates (ADCs). The Company is advancing its unique ADC technology to transform the treatment paradigm for patients with hematologic malignancies and solid tumors.
ADC Therapeutics’ CD19-directed ADC ZYNLONTA™ (loncastuximab tesirine-lpyl) was just approved by the FDA on April 23, 2021 for the treatment of adult patients with relapsed and refractory diffuse large B-cell lymphoma. The approval was granted one month ahead of the Prescription Drug User Fee Act (PDUFA) date.
The Company develops ADCs by combining its decades of experience and next-generation pyrrolobenzodiazepine (PBD) technology to which ADC Therapeutics has proprietary rights for its targets. The Company has multiple ADCs in ongoing clinical trials, ranging from first in human to pivotal Phase 2 clinical trials, in the US and Europe, and numerous preclinical ADCs in development.
ADC Therapeutics is based in Lausanne (Biopôle), Switzerland and has operations in London, the San Francisco Bay Area and New Jersey. To learn more about ADC Therapeutics, please visit us at https://adctherapeutics.com/ and follow us on Twitter and LinkedIn.
Position Overview
The Associate Director, Pharmacovigilance (PV) Systems will be responsible for supporting various aspects of PV systems, as well as alliance management, signal management, quality oversight and training activities. The position will assist in providing expertise, leadership, and collaboration for internal and external customers, to ensure overall PV excellence and regulatory compliance.
The Associate Director, Pharmacovigilance Systems will report to Senior Director, Global Pharmacovigilance Operations and will be based in the New Jersey office.
Job Responsibilities
- Work with the Sr. Director, PV Operations to support implementation/maintenance of PV systems and associated processes, alliance management, signal management, quality oversight and training activities.
- Manages signal detection vendor and collaborate with Safety Physician team to ensure all signal management activities meet regulatory and compliance standards.
- Leads the development of PV agreements with license partners and/or other parties as required.
- Provide PV quality oversight for PV audits, inspections, CAPA activities as required.
- Prepares and maintains Drug Safety departmental policies and SOPs that address PV systems, alliance management, signal management, quality oversight and training activities.
- Lead and maintain oversight on PV documentation and record retention in Drug Safety department.
- Lead the development and maintenance of Pharmacovigilance System Master File.
- Support IND, BLA and MAA regulatory submissions from safety system perspective.
- Ensures awareness and training of appropriate Company personnel and external groups of PV on Drug Safety principles, policies, and SOPs.
- Provides PV guidance and support for interdepartmental and/or corporate initiatives.
. Requirements:- Health care degree (RN, PA, or Pharm D).
- Extensive drug safety experience and solid knowledge of drug development highly desirable.
- 7+ years of PV operations experience within the biotechnology or pharmaceutical industry.
- Expert knowledge of global PV requirements, e.g., US Code of Federal (CFR) regulations, European Union (EU) Guideline on Good Pharmacovigilance Practices (GVP) and ICH Guidelines.
- Experience and extensive working knowledge of proprietary safety databases; experience with Argus a plus.
- Experience managing business process outsourcing vendors and relationships; PV processes for individual cases and medical review; aggregate data assembly and clinical study safety management.
- Experience and extensive working knowledge of signal detection and evaluation, review, working with license partner and PV agreement.
- Experience and extensive working knowledge on PV quality management, training, document management, audits, and inspections.
- Strong relationship building skills with ability to interact effectively in a multifunctional, multicultural, growing organization.
- Strategic thinking, strong organizational and analytic skills, project management, excellent verbal, written communication skills, attention to detail.
- Proficient with Microsoft Office.