- The Principal PV Compliance Manager is responsible for managing compliance activities and supports the development and implementation of the strategic vision and initiatives of global PV Compliance. Principal responsibilities include but are not limited to:
- Perform accountabilities for the following primary functions:
- Compliance/ Audit/ Inspection related activity
- Non GxP Guidance
- Lead projects and provide regional insight to global projects where applicable.
- Perform root cause analysis and implementation of process improvement strategy to ensure alignment with business objectives.
- Represents Compliance function internally and externally
location: Cambridge, Massachusetts
job type: Contract
salary: $45.00 - 50.87 per hour
work hours: 9 to 5
- Provide leadership for compliance related issues and advise PV management team of potential issues and solutions
- Prepare data, interpret and perform impact analysis regarding metrics for case processing and regulatory expedited reporting to regulatory authorities and Local Operating Companies (LOCs)
- Manage the investigation of non-compliance (deviations) and implementation of corrective measures where required
- Develop and distribute regular reports regarding global compliance activities to key stakeholders
- Perform impact analysis for PV compliance strategies and working practices, including input into safety exchange agreements, CRO oversight, SOPs, and other pertinent PV processes
- Serves as the key contact in the region for internal and external pharmacovigilance audit responses as subject matter expert; responsible for communicating audit results to PV senior management team
- Support global efforts to ensure PV regulatory inspection or internal audit readiness for dedicated PV or GCP inspections/audit
- Address more complex audit/inspection findings as needed
- Oversee compliance with global corrective and preventative action plans (CAPAs)
- Partner with LOCs and Drug safety Officers (DSOs) in local inspection/audit activities as needed
- Monitor and manage all CAPAs for GPSE to enable on time CAPA completion. Proactively work cross functionally to ensure on-time CAPA completion.
- Escalate issues/problems to management as needed
- Actively contribute to the development of processes, applications and methodologies in the department.
- Perform other tasks assigned by to assist in departmental activities
- BS, RPH, RN HCP, or Life Science required; Post-graduate degree or equivalent preferred
- Post-graduate degree or equivalent with moderate experience in the pharmaceutical/biotech industry
- Reasonable relevant experience or participation in pharmacovigilance and/or GCP audits/inspections
- In depth knowledge and comprehension of Pharmacovigilance regulations, compliance practices and ability to interpret multiple requirements into concise clear instructions.
- Familiarity with inspections and audit procedures
- Works strategically to realise organizational goals
- Critical thinking and decision-making skills
- Exercise independent judgment
- Understanding Company business needs with global business perspective and professional attitude
- Excellent level of computer literacy with Microsoft applications
- Excellent organization skills and ability to prioritize
- Demonstrate integrity
- Relate well to people at all levels
- Motivate and empower others
- Work productively in a high pressure environment
- Ability to identify proactively and anticipate risk of non-compliance in a complex environment
- Knowledge of compliance international Regulations and ICH environment foundations
- Good analytical/judgment capabilities to understand/analyze/synthesize and communicate
- Project Management abilities
- Strong knowledge of business area and interactions with strong regulatory environment and ability to identify and understand proactively the interactions necessary for achieving business goals and objectives
- Able to manage both time and priority constraints and to manage multiple priorities simultaneously
- Attention to details, computer literacy, knowledge of safety database
- Take initiative and autonomous action
- Able to lead teleconferences and meetings
- Proven ability to work in international environment and with cross-functional teams, with good interpersonal skills / assertiveness / team spirit / caching skills
- Routine demands of an office based environment.
- Estimated 0-5 times per year, including possible international travel.
- Minimum 6 years of experience in the pharmaceutical/biotech industry
- Minimum 4 year relevant experience or participation in pharmacovigilance and/or GCP audits/inspections
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.