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Pharmacovigilance Quality Project Leader

Parexel International Corporation

France - Any Region - Home Based

We are now looking for a PV Quality Project Leader to join our team in France

In this role, you will partner with our Global CHC Pharmacovigilance teams, Local Pharmacovigilance teams, Regulatory, and Clinical as well as with colleagues from other Quality operational units as required

JOB PURPOSE: Ensuring a sustainable compliant and robust quality system meeting all regulatory and legal requirements related to PV activities. Creates, enables and maintains a PV quality system which mandates from global, to country level a state of control on monitoring and tracking systems with regards to all pharmacovigilance activities. Identify potential risks of non-compliance and establishes and oversees improvement programs to mitigate the risks

KEY RESULTS/ACCOUNTABILITIES: Quality Documents & training operations: Maintenance of Quality documents (QDs) applicable for CHC PV in line with global quality directives and QD architecture Ensure timeliness and quality of PV Quality documents in the Electronic Document Management System PV Audit and inspection readiness: the incumbent participates to: The ongoing permanent inspection preparedness and readiness of CHC PV and country PV offices in anticipation to Regulatory inspections and audits. The organization of appropriate support for the preparation, conduct and follow up of regulatory inspections impacting PV until closure. The organization of appropriate support for the preparation, conduct and follow-up of Global Quality audits or Business Partner audits, impacting global PV processes, until closure. The regular oversight of audit/inspections PV related Corrective and Preventive Actions (CAPAs) to ensure timely completion and effectiveness to prevent recurrence. External relations with Inspectorates / Agencies / Pharma associations to ensure surveillance of PV inspections regulations/practices and benchmark on recurrent inspection PV findings. Conduct Routine Compliance activities and tasks related to ICSR, PSR submissions to Health Authorities Provide KPI related to CHC for Weekly, Monthly, Quarterly meetings and reports to management. Run compliance investigations and Root Cause Analysis, jointly with affiliates, CHC PV stakeholders or external partner, ensuring true root cause is identified Identify potential critical and major systemic deviation and escalate as required Identify Trends during ongoing investigations and as part of retrospective reviews. Participate to the remediation of compliance gaps in collaboration with stakeholders owning the corrective and preventive actions (CAPA) PV Retrospective QA checks and deviations management Ensure oversight and controls on PV systems (activities e.g. Individual Case Safety Report management) or PV output (PSUR, etc…) are performed routinely as defined. Ensure consistency in quality measures Ensures a global system to track and monitor investigation of all identified quality gaps, quality risks and ensure that Corrective and preventive Action Plans are implemented Perform trend analysis on QAs results and deviations and analyze effectiveness of corrective/preventative action and re-adjust the measure Quality Vendor Oversight: Implementation of global vendor qualification standards and processes to track vendor assessments for PV and oversee the level of quality of their deliverables QualificationsSKILLS, EXPERIENCE & KNOWLEDGE REQUIREMENTS Scientific background: Pharm D or Master Degree in Human Health Sciences with Minimum 2-3 years’ experience in Pharmacovigilance activities. Experience dealing with audit and inspections would be a plus. Capability to work under extreme pressure. Excellent communication skills (oral and written). Experience in pharmacovigilance and in the field of PV inspections. Excellent organizational and planning capabilities. Ability to work in transversal/cross functional teams. Excellent teamwork and interpersonal skills.

Job posted: 2022-05-17

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