What are the responsibilities and job description for the Drug Safety Associate position at The Fountain Group?
Details for the position are as follows:
- 6-month contract to start with the possibility of extension depending on performance.
- Pay: $25 - $27.85 per hour.
- Location: Basking Ridge, NJ (local candidates preferred; must be able to come onsite at least once a week).
Job Description:
This position supports the Head of PV Quality Management in the delivery and oversight of global and regional pharmacovigilance (PV) quality management activities, including:
- Compliance and performance monitoring:
- Coordinates activities for monitoring key performance indicators (KPIs) and compliance metrics.
- Collects and documents data related to non-compliance, signal management, and adherence to PV agreements.
- Quality support:
- Supports CAPA management and tracks implementation of corrective actions.
- Ensures internal processes are evaluated and improved.
- Inspection and audit readiness:
- Prepares PV subject matter experts (SMEs) for inspections/audits.
- Collaborates with the Global R&D/PV-QA Audit team to manage pre-, during, and post-audit activities.
- Training program management:
- Coordinates onboarding and training activities for PV functions.
- Maintains training documents and role-based curricula.
- Procedural document management:
- Manages lifecycle of PV-related policies, SOPs, and associated forms/templates.
- Updates documentation in alignment with process improvements.
Required Skills:
- 1 years of pharmacovigilance experience in a pharmaceutical environment (internship/co-op experience counts).
- Bachelor's degree required.
- Knowledge of FDA regulations, EU regulations, and ICH guidelines.
- Understanding of Good Clinical Procedures (GCP) and Good Pharmacovigilance Procedures (GVP).
Salary : $25 - $28
