Pharmacovigilance Operations Manager

The Pharmacovigilance Operations Manager supports the global safety system and associated data mart to ensure accurate, compliant, and timely safety data analytics and reporting, while advancing the use of automation, artificial intelligence (AI), and innovative technologies where appropriate. This role supports system changes and configurations, maintains data integrity, enables regulatory and business reporting, and delivers training for technical and business users. Operating with limited direction from the Senior Manager, this position plays a critical role in inspection readiness, regulatory compliance, and the responsible adoption of innovative solutions within the pharmacovigilance environment.

Key Responsibilities

Global Safety System & Data Support

• Support changes to the global safety system and associated data mart.
• Support implementation of global safety system configurations, including reporting rules, product, and study setup.
• Ensure integrity, consistency, and reliability of safety data used for analytics and reporting.
• Contribute to the development and maintenance of technical solutions supporting safety system functionality and outputs.
• Support and participate in User Acceptance Testing (UAT) for safety system changes.
• Partner with Safety Technology team colleagues and Managed Services to optimize system support

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Safety Data Outputs & Regulatory Reporting

• Triage, analyze, prioritize, and fulfill requests for safety data outputs.
• Generate safety data outputs to support:Periodic safety reports (e.g., PADER, PSUR, DSUR), Signal detection activities & Audits, inspections, and regulatory inquiries
• Ensure timely delivery of automated and scheduled safety data outputs.
• Perform quality checks and peer reviews for safety data outputs.
• Configure safety systems to support routine safety data outputs, including:Development of user reports, Creation of Query By Example (QBE) & Augment and define search strategies in collaboration with functional leads to ensure consistent and reliable outputs.
• Participate in the collection of business requirements for routine safety data outputs.

Study & Integration Support

Support study start-up activities, including:

• Electronic Data Capture (EDC) [RAVE/Veeva]–Safety Database mapping [LSMV/Argus]
• Mapping Specifications Worksheet (MSW) review and approval
• UAT execution and documentation

Automation & Innovation

• Actively identify and support opportunities to leverage artificial intelligence (AI), automation, and advanced analytics to improve safety data quality, efficiency, and insight generation.
• Contribute to the evaluation, implementation, and validation of innovative technologies (e.g., AI-assisted case processing, signal detection, reporting automation) within the global safety system landscape.
• Partner with cross-functional stakeholders (IT, Data Science, PV Operations, Compliance) to pilot and operationalize innovative solutions while ensuring regulatory compliance, data integrity, and inspection readiness.
• Stay informed of emerging technologies, industry trends, and regulatory expectations related to AI and advanced analytics in pharmacovigilance.
• Support governance, documentation, and change management activities related to AI-enabled tools and innovations to ensure sustainable and compliant adoption.

Training & Process Development

• Participate in and/or lead the development and delivery of training for safety databases, reporting tools, and associated processes.
• Assist with or lead the development of system support processes, SOPs, work instructions, and user manuals.
  

Compliance & Inspection Readiness

• Undertake activities delegated by the Qualified Person for Pharmacovigilance (QPPV) as defined in the PV System Master File.
• Maintain a continuous state of inspection readiness.
• Serve as a representative and point of contact for:
• Health Authority inspections
• Internal process audits
• Audit responses within the scope of role responsibilities

Knowledge, Skills, and Experience

Technical & Functional Expertise

• Strong knowledge of pharmacovigilance safety systems (preferably the ArisGlobal's LifeSphere platform).
• Experience with reporting and analytics tools such as Cognos, Spotfire and Tableau.
• Working knowledge of Oracle databases, Oracle Developer, and programming languages (e.g., Python, PL/SQL).
• Understanding of data warehouse concepts and data mining techniques.
• Understanding of the software development lifecycle (SDLC), validation methodologies, and development standards.

Regulatory & Domain Knowledge

• Solid understanding of global pharmacovigilance regulations and safety reporting requirements.
• Understanding of clinical trial and pharmacovigilance processes.
• Familiarity with statistical analysis and interpretation of aggregate safety data.
• Experience supporting regulatory inspections or internal audits.

Professional Skills

• Strong organizational, prioritization, and planning skills.
• Ability to manage deliverables independently with minimal supervision.
• Proactive problem-solving skills with the ability to recognize and escalate issues appropriately.
• Strong written and verbal communication skills.
• Ability to build effective cross-functional relationships.
• Demonstrated leadership capabilities.

Experience

• Pharmaceutical industry and/or health authority experience required.
• Prior experience supporting pharmacovigilance systems, safety data analytics, or regulatory reporting strongly preferred.
• Case management experience is strongly preferred.

Education

• Master’s degree OR
• Bachelor’s degree and 2 years of directly related experience OR
• Associate’s degree and 6 years of directly related experience OR
• High school diploma / GED and 8 years of directly related experience