Provide Pharmacovigilance related quality and compliance oversight, training and continuous improvement opportunities to Pharmacovigilance and other business partners through assessment of Pharmacovigilance systems and operations, development of appropriate standards, KPI and metrics, identification of quality and regulatory compliance issues and support of remediation and Health Authority and audit CAPA follow-up.
1. Contribute to Pharmacovigilance and development Quality Plan and execute deliverables.
2. Identify and communicate regulatory compliance issues to Pharmacovigilance QA management. Provide assistance with the remediation of compliance concerns and provide ongoing project support and governance, as assigned.
3. Lead initiatives focused on quality improvement and compliance quality initiatives for quality readiness. Through close collaboration with business partners, identify opportunities for improvement and develop strategies aimed at simplifying processes and improving quality of outputs while ensuring compliance with regulatory requirements. Support Pharmacovigilance with compliance investigations and initiatives focused on quality readiness.
4. Independently review, evaluate and approve proposed corrective and preventative action plans (CAPA) in collaboration with the responsible business unit. Monitor and track status of corrective and preventative actions to ensure that the issues are adequately addressed and completed on time. Provide leadership to drive closure of audits through close collaboration with involved business units and partners. Prepare routine overview of outstanding CAPA items.
5. Prepare for, facilitate and lead logistics for Health Authority Pharmacovigilance inspections, assess results of pre-inspection activities and HA inspection findings in terms of associated risks and communicate to management, provide input to CAPA to ensure quality, consistency and appropriateness of commitments. Interface and communicate with regulatory authority representatives as required. Follow-up and tracking of CAPA to drive to completion.
6. Independently evaluate information gained during initiatives focused on compliance and quality improvement, as well as audit and assessment results, to identify specific regulatory, compliance and quality assurance training needs for business partners. Lead the development, implementation and conduct of appropriate training.
7. Review and advise on relevant guidelines, policies, Quality Modules and Directives, SOPs (Standard Operating Procedures) and Processes.
8. Proactively research and monitor local and global quality improvement initiatives, trends and events that impact maintenance of compliance as well as changes to global PV regulations, guidelines, policies and procedures. Lead initiatives with business partners to ensure adequate integration into business practices.
9. Contribute to the development of an effective risk-based audit strategy and pro-gram.
10. Utilize professional competence to support Pharmacovigilance and other business partners with compliance investigations and initiatives focused on inspection readiness and quality, process and compliance improvement. Analyze root causes for non-compliance through process review. Formally document outcomes. Identify issues and recommend conduct of formal investigations; sign-off investigations.
*BA/BS or equivalent
*Advance degree desirable
*English fluency at operational and functional level (as first or second language; fluency in second language a plus)
*5 plus years Quality and PV/clinical/industry/health authority experience with quality auditing experience;
* 30% travel
* Ability to independently manage and objectively evaluate complex compliance issues with minimal supervision;
* Ability to address a variety of tasks within the same timeframe while maintaining oversight; ability to maintain a high degree of independence with respect to decision making and problem solving;
* Ability to work in a cross functional and global matrix structure
* Extensive experience with Health Authority inspections and interaction;
* Excellent quality and compliance leadership and facilitation skills;
* Excellent verbal and written communication, organizational and interpersonal skills;
* Excellent computer skills, including Excel, Word, etc;
* Extensive knowledge of applicable PV, GCP and GxP regulations, guidelines, policies and procedures;
* Good knowledge of computer validation and Part 11 requirements;
* Ability to lead teams and operate successfully in various team capacities;
* Appreciation of and ability to operate successfully in diverse cultural environments and teams
* Auditor certification a plus.
Novartis AG, incorporated on February 29, 1996, is a Switzerland-based holding that, through its subsidiaries, is engaged in the research,...