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Showing: 1 Associate Director, PSPV Compliance & Analytics jobs in Cambridge, Massachusetts
Associate Director, PSPV Compliance & Analytics
Spectraforce
Cambridge, Massachusetts
Remote

17 days ago

Job Description

Position Title: Associate Director, PSPV Compliance & Analytics
Work Location: Cambridge, MA – 100% Remote
Assignment Duration: 6 months (Possible Extension)
Work Arrangement: 100% Remote
 
Position Summary:
  • 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.
 
Background & Context:
  • Describe at the highest level the team where this job sits and how this role will contribute to the team’s delivery of critical function.
 
Key Responsibilities:
  • 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
 
Qualification & 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
  • Project Management experience is a plus
  • Excellent organization skills and ability to prioritize
  • Demonstrate integrity
  • Good analytical/judgment capabilities to understand/analyse/synthesize and communicate
  • Able to manage both time and priority constraints and to manage multiple priorities simultaneously
  • Take initiative and autonomous action
  • Able to lead teleconferences and meetings
  • Proven ability to work with cross-functional teams, with good interpersonal skills / assertiveness / team spirit / caching skills
  • Bachelor of Science degree in medical or science related field; post-graduate degree or equivalent a plus
  • Excellent interpersonal, communication, and organizational skills
  • Excellent level of computer literacy with Microsoft applications
 

Applicant Notices & Disclaimers
  • For information on benefits, equal opportunity employment, and location-specific applicant notices, click here
 


At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $100.00/hr.

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