Director/Senior Director Safety Physician

Alpha Clinical Laboratory Inc; New Jersey; Hybride; USD 180 000 - 260 000; Plein temps

Résumé du poste

Alpha Clinical Laboratory Inc. is seeking a Senior Director/Director Safety Physician in Oncology to oversee all Patient Safety activities for assigned compounds. The role involves leading cross-functional Safety Monitoring Teams, evaluating safety signals, and representing GPS in internal and external committees.

A strong MD background with FDA, EU, and ICH pharmacovigilance expertise is required. The position is hybrid, permanent, and located in New Jersey.

Qualifications

• MD required or equivalent; strong background in pharmacovigilance
• Experience leading safety activities for oncology programs and regulatory interactions
• Excellent communication and ability to defend safety findings to cross-functional and external bodies

Responsabilités

• Oversee safety activities for assigned oncology compounds.
• Lead safety signal detection and risk management activities.
• Prepare and review DSURs, PSURs, and RMPs.
• Provide safety input on protocols and study reports; influence safety sections.

Connaissances

Pharmacovigilance leadership

Cross-functional leadership

FDA/EU/ICH guidelines

Safety data management

Formation

MD degree

Outils

MedDRA

Description du poste

Overview

• Oversee Patient Safety activities for assigned oncology compounds.
• Prepare and review safety documents (DSURs, PSURs, RMPs).
• Requires MD and expertise in FDA, EU, and ICH pharmacovigilance guidelines.

Position summary:

• Oversee Patient Safety activities for assigned oncology compounds.
• Prepare and review safety documents (DSURs, PSURs, RMPs).
• Requires MD and expertise in FDA, EU, and ICH pharmacovigilance guidelines.

This Senior Director/Director Safety Physician role in Oncology involves overseeing all Patient Safety activities for assigned compounds. Key responsibilities include managing safety signals, responding to regulatory queries, preparing and reviewing safety documents (DSURs, PSURs, RMPs), and providing safety input on clinical documents such as protocols and study reports. The role requires leadership of cross-functional Safety Monitoring Teams and representation of GPS on internal and external committees, including safety oversight and independent data monitoring teams. The candidate must proactively develop strategies for GPS activities, participate in SOP development, and engage in continuous improvement efforts.

Requirements include expertise in applying FDA, EU, and ICH guidelines for pharmacovigilance in clinical trials and post-marketing, acting as an internal and external safety expert, and using safety databases for case reviews. Strong communication skills to present and defend safety findings and risk management strategies are essential, and an MD is highly preferred.

Job Nature

Hybrid, Permanent

Experience Requirements

10-15

Job Location

New Jersey, US

Job Level

Sr. Position