Collaborate with Patient Safety (PS) Global Process Leads (GPL) and Global Process Owners (GPO) to develop a quality/compliance framework to assess health of the processes, leveraging asset intelligence as needed.
Ensure quality oversight of PS processes through continuous monitoring of regulatory compliance and risk mitigation, adhering to all applicable GVP guidelines, regulations, and inspectorate expectations to maintain quality excellence.
Key Responsibilities
- Quality and Compliance Quality Monitoring
- Develop and execute quality and compliance monitoring activities for PS processes within area of expertise to support a robust GVP Quality Management System.
- Data Collation and Analysis
- Collate data from PS GPL and GPO, PV Compliance and QRM Team. Use appropriate tools to analyze these datasets, identifying trends or issues to surface specific process health. Analyze datasets to identify trends, patterns, and insights that support quality and compliance, demonstrating system health through adherence to PS and regulatory commitments.
- Reporting and Visualization
- Create and present reports and visualizations to stakeholders, translating complex quality and compliance PS data into understandable and actionable insights.
- Collaboration and Communication
- Collaborate between the subject matter expert functional/group leads and the Head of PV Process Excellence to drive continuous quality improvement through regular communication about quality trends and process reinforcement.
- Strategy Evaluation
- Continually evaluate the effectiveness, outcomes and relevance of QM programs, and recommend revisions to strategy based on results, business risks, and feedback from internal and external sources.
- Stakeholder Management
- Ensure effective communication with key PS stakeholders related to the PS processes, reviewing their performance metrics to ensure expectations are met and delegated functions are performed in accordance with contractual and regulatory requirements. Escalate any suspected compliance or quality concerns associated with in-house or outsourced pharmacovigilance activities. Plan remediation actions in collaboration with GPO/L and respective stakeholders when vendor performance or compliance expectations fall short.
- Process Improvement
- Partner with the Global Process Owners/ Process Leads, Director PV Process Excellence, and other key stakeholders to proactively identify opportunities for process improvement, increasing the effectiveness and efficiency of the PS organization.
- Inspections and Audits:
- Participate and provide information in support of PS inspections and audits and collaborate with SMEs and PV Quality Assurance including actioning feedback aimed at continuous improvement.
- Tools and intelligence
- Define quality and compliance business requirements and collaborate with IT for timely delivery of enhancements and new functionalities. Collaborate with cross-functional teams, including PS stakeholders, i. e. PVQA and IT, to articulate the business need for technical, analytical solutions to accomplish holistic views of health of the PV systems.
Key Competencies
Critical Thinking
- Critically evaluates different options based on evidence and context to form reasoned judgments.
Data Management
- Monitors and reviews data with an eye for anomalies and patterns to identify trends.
Strategic thinking
- Understands the role of basic digital tools in achieving specific operational goals and can articulate simple digital-based strategies.
Decision-Making
- Uses data summaries to support decisions based on clearly defined options and guidelines.
Qualifications & Experience
- B. S. N. /RN, B. A. /B. S. /M. S. (Life Sciences); B. S. Pharm. /R. Ph. /Pharm. D. or equivalent
- 8 plus years pharmaceutical industry experience, including significant pharmacovigilance , drug development , clinical development or regulatory affairs experience.
- Extensive knowledge of worldwide regulations pertaining to pharmacovigilance
- Proven experience with analyzing data from multiple sources, with a focus on pharmacovigilance or drug safety.
- Proficiency in data visualization tools such as Tableau, Power BI, or AI and machine learning similar strongly preferred
- Excellent analytical and problem-solving skills with keen attention to detail.
- Prior quality and compliance related experience in pharmacovigilance preferred.
- Prior experience with providing guidance to senior management on regulatory and compliance issues germane to pharmacovigilance.
- Successful and creative negotiation of difficult compliance issues.
- Demonstrated ability to work in a complex, changing environment and be accountable for actions and results.
