What are the responsibilities and job description for the Senior Drug Safety Specialist, Drug Safety & Pharmacovigilance Operations position at Apex Systems?
Job# : 2062974
Job Description :
Senior Drug Safety Specialist, Drug Safety & Pharmacovigilance Operations 2062974
Location : Cambridge, MA (Hybrid)
Science : Small Molecule
Job Overview : This is a pivotal role within our clients Drug Safety and Pharmacovigilance Operations team, responsible for processing Individual Case Safety Reports and ensuring adherence to SOPs, policies, and regulations across both clinical and post-marketing phases.
Primary Job Responsibilities :
- Provide PV support for clinical studies, streamlining study processes, and collaborating with DSPV and other teams for study deliverables.
- Oversee vendor quality for adverse event processing, case review, and ensure compliance with reporting timelines and reconciliation activities.
- Enhance Drug Safety operations by supporting quality management, compliance monitoring, and maintaining high standards in training and documentation.
Primary Job Requirements :
