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.

Find out exactly what skills, experience, and qualifications you will need to succeed in this role before applying below. Contract: 6-months Pay: $130-150 hourly Hybrid Schedule, available for occasional onsite in Cambridge, MA 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 Education & Experience: 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 By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy at Privacy Policy