Pharmacovigilance Compliance & Training Associate - Incyte
Location: Wilmington, DE
Under the leadership of the Manager, Pharmacovigilance (PhV) Compliance and Training, this position provides support in evaluating the quality and compliance of the PhV organization through established training and compliance monitoring systems. Responsible for tracking and following up on Incyte PhV Department corrective and preventive action (CAPA) and training activities including ensuring the maintenance of adequate documentation. Assists with the maintenance of standard operating procedures (SOPs) and Work Instructions (WIs), and training in relation to Pharmacovigilance. May be required to assist with internal audits of safety reporting systems and procedures to ensure quality, integrity, and compliance with regulations relevant to Pharmacovigilance and Safety reporting.
Summary of the Essential Functions of the Job:
- Manages compliance tracking, periodic compliance reports, process deviations, and corrective and preventive action (CAPA) process
- Perform follow-up on pending CAPAs and maintain tracking mechanism for Incyte PhV departmental deviations to ensure timely resolution. Maintain compliance records to ensure continuous availability for inspection.
- Reviews and approves departmental SOPs, work instructions, and conventions
- Actively participate in the development, implementation, and maintenance of Pharmacovigilance training programs and initiatives. Responsible for tracking and maintaining all training documentation for Incyte PhV, PhV service provider, and other vendors (e.g., Specialty Pharmacy).
- Ensure appropriate documents are stored in shared documentation systems when applicable
- Collaborate with other departments to ensure appropriate collection and handling of safety data
- Update drug safety forms and templates in harmonization with relevant clinical operations forms and templates (i.e. Call Center form, SAE data collection form, Case Report Form)
- Participates in implementation of process improvements with a view to increased efficiency and effectiveness
- Contributes to the management and maintenance of the Pharmacovigilance System Master File or similar document, as requested
- Help ensure that PhV staff is updated on the most current domestic and international regulations relevant to a Drug Safety organization (e.g., ICH guidelines, FDA, EU, or other national/international requirements)
- Participate in special projects to support departmental initiatives
- Perform other duties as assigned
- BA/BS or equivalent experience in a drug safety or clinical environment with a minimum of 2 to 4 years of direct drug safety and pharmacovigilance experience
- Experience in Biotech/Pharmaceutical industry required
- Experience in liaising with vendors/CROs preferred
- Understanding of drug safety processes, FDA and other national or international regulations, and ICH guidelines required
- Contributes to successful completion of programs, projects, and/or functions
- Identifies/implements methods, techniques, procedures,& evaluates criteria to achieve results
- Demonstrates strong analytical/problem-solving skills
- Contributes to technical and/or business solutions to complex problems
- Demonstrates ability to manage multiple projects concurrently
- Possesses excellent business communication skills (oral and written)
- Demonstrates strong interpersonal/organizational skills as well as a team-oriented approach
- Possesses strong computer skills in drug safety applications, Microsoft Office Suite (Word, Excel, and PowerPoint).