Details for the position are as follows:
The Associate director, PSPV Compliance & Analytics is responsible for managing compliance metrics, analytics, and leading compliance-related activities in support of the strategic vision and initiatives of the global PV Compliance function. Principal responsibilities include but are not limited to:
- 6 month contract to start with the possibility of extension or conversion depending on performance and budget.
- Rate: $140-150.35 an hour.
- Location: Manage is open to 100% remote candidates that can work ET hours or candidates who can work Hybrid out of Cambridge, MA
The Associate director, PSPV Compliance & Analytics is responsible for managing compliance metrics, analytics, and leading compliance-related activities in support of the strategic vision and initiatives of the global PV Compliance function. Principal responsibilities include but are not limited to:
- Generate, analyze and oversee compliance metrics for case processing, aggregate safety reporting (including regulatory expedited and periodic reporting to regulatory authorities), and other relevant compliance metrics, with investigation of non-compliance and implementation of corrective measures where required;
- Oversee and perform late Individual Case investigations, root cause analysis and implementation of process improvement strategy to ensure alignment with business objectives.
- Lead the investigation of late Individual Case Safety Reports (ICSR) submitted to Health Authorities and/or Business Partner, and implementation of corrective and preventive measures, as required
- Generate data, interpret, and perform impact analysis regarding metrics for case processing and regulatory expedited reporting to regulatory authorities and Local Operating Companies (LOCs), including periodic trend analysis.
- Develop and share compliance metrics reports regarding global compliance activities to key stakeholders
- Implement and/or perform Quality Check (QC) activities, as required
- Provide oversight of vendor management activities, as required, which support the Pharmacovigilance compliance department
- Support global efforts to ensure PV regulatory inspection or internal audit readiness for dedicated PV or GCP inspections/audit
- Act as subject matter expert in audits and inspections, where required, and address audit/inspection findings, as needed
- Monitor and manage CAPAs for PSPV to enable on time CAPA completion. Proactively work cross functionally to ensure on-time CAPA completion.
- Partner with LOCs and Drug safety Officers (DSOs) in local inspection/audit activities as needed
- Escalate issues/problems to management, as needed
- Contribute to development of processes and process improvements, as assigned
- Perform other tasks assigned by line manager to assist in departmental activities
- Contribute to business continuity strategies for the activities under their accountability.
- BS, RPH, RN HCP, or Life Science required; experience in the pharmaceutical industry with at least 5 years of relevant experience in pharmacovigilance compliance
- In depth knowledge and comprehension of pharmacovigilance regulations and compliance.
- Knowledge of compliance international Regulations and ICH environment foundations
- Experience with inspections and audit procedures
- Ability to identify proactively and anticipate risk of non-compliance in a complex environment
- Excellent level of computer literacy with Microsoft applications
- Proficiency in safety-related databases (e.g. Argus) and in generating and analyzing compliance metrics