Proclinical is advertising a vacancy for a Pharmacovigilance Functional Strategy Lead, Associate Director Quality Assurance position with one of the largest CROs in the global market. This organisation specialises in technology advancements and access to real world data. The Strategy Lead, Associate Director will join this company in their office based in Ireland.
The Pharmacovigilance Functional Strategy Lead, Associate Director Quality Assurance will become a trusted partner to the function head and team. They will provide prospective, strategic QA input into operational improvement initiatives, along with QA analytics and insights to drive continuous improvement. They will always ensure robust and effective issue management and assisting operations to maintain inspection readiness in rapidly evolving clinical development and regulatory environments.
Job Responsibilities:
- Conducting annual Process Robustness Assessment and ongoing risk analysis of Pharmacovigilance (PV) systems and processes to recommend process audits for the Global Annual Audit Plan.
- Reviewing process audit plans and audit reports and supporting the audit team in agreeing the CAPAs.
- Working with PV counterparts to maintain Key Core Processes (KCPs) and associated EDA classifications.
- Monitoring progress with PV Process Owners' strategies and action plans to improve existing KCPs.
- Supporting the investigation of current/recurring key issues or findings related to PV by reviewing the existing processes, identifying gaps with CAPAs, and making recommendations to the Lead QA and operations.
- Supporting and overseeing/facilitating the processing of Quality Issues in accordance with CS_OP_002 (Managing Critical Process-Related Qis and Critical Multi-Customer related Qis as Lead QA and Providing Consultation on the review of CAPAs, Critical Notification Forms, and Serious Breaches) for PV.
- Maintaining an oversight of the status of approved preventative actions to address improvement opportunities with PV processes.
- Working with the PV Functional Head and their representatives to ensure efficient and timely processing of audit reports/findings and Quality Issues in their domain.
- Monitoring, cataloguing, proactively contributing to, tracking the actions agreed form, and working with operations to establish the effectiveness of improvement initiatives undertaken by PV.
- Monitoring, cataloguing, proactively contributing to the development of new service offerings relating to PV and working with operations to establish the effectiveness of those offerings.
- Providing consultancy and input into incremental process improvements, such as advising on SOP content.
- Maintaining an up-to-date knowledge of emerging regulations, emerging/changing interpretations of regulations, changing expectations of regulatory inspectors, assessing the risks and feedback recommendation to PV, and supporting operational management in interpreting regulations.
- Maintaining strong links with Customer Account Leads to monitor emerging/changing expectations of customers with respect to PV's systems and processes, assessing the risks, and feedbacking recommendation to the function.
- Hosting or supporting Regulatory inspections as the SME for PV.
- Hosting or supporting customer audits as the SME for PV.
- Reviewing audit findings and Quality Issue/Nonconformance events as they related to PV on an ongoing basis.
- Conducting trend analyses.
- Identifying QA insights to feedback to PV management.
- Producing periodic QA reports on PV performance.
- Facilitating periodic management quality reviews with PV and capturing and tracking agreed actions.
- Collaborating with Quality Managers to remain aligned on emerging Operational risk trends.
- Supporting QA colleagues in the oversight of the practices of other Business Areas conducting work allied to PV.
- Providing updates and overviews of the insights and initiatives associated with PV.
- Sharing the identified KCP level action plans with others in QA to prevent repetitive Preventative action plans.
- Contributing ideas for improvements in the services of the Functional Strategy Team, and to the development of new, more impactful, and efficient ways of working.
Skills and Requirements:
- At least 5 years of experience working in Pharmacovigilance Quality Assurance.
- Strong working knowledge of quality assurance processes and procedures.
- Demonstrable experience in maintaining up-to-date knowledge of regulatory requirements, including changes in requirements and expectations.
- Experience working with a CRO is desirable, but not a prerequisite.
- Experience in hosting customer audits and regulatory inspections is an advantage, but not a pre-requisite.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
To Apply:
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Joshua Godden at +442038540101 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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