Pharmacovigilance Operations Manager
Job ID: R-232968
Location: Hyderabad, India
Work Mode: On-site
Employment Type: Full-Time
Functional Area: Pharmacovigilance | Drug Safety Systems | Safety Analytics
Experience Required: 6–10+ years (role-dependent)
Date Posted: December 22, 2025
Role Overview
The Pharmacovigilance Operations Manager plays a strategic role in supporting and optimizing the global safety system and safety data mart, ensuring accurate, compliant, and timely safety analytics and regulatory reporting. This position contributes to inspection readiness, system governance, and continuous improvement initiatives, including the responsible adoption of automation, artificial intelligence (AI), and advanced analytics within the pharmacovigilance environment.
Operating with limited supervision from senior leadership, this role collaborates closely with Safety Technology, Pharmacovigilance Operations, Compliance, IT, and Data Science teams to maintain data integrity, regulatory compliance, and operational excellence across global safety programs.
Key Responsibilities
Global Safety Systems & Data Management
Support enhancements, configurations, and changes to the global safety system and associated data mart.
Maintain system configurations related to products, studies, reporting rules, and workflows.
Ensure accuracy, consistency, and reliability of safety data used for analytics and reporting.
Participate in User Acceptance Testing (UAT), system validation, and release activities.
Collaborate with Safety Technology teams and Managed Services partners to optimize system performance and support.
Safety Data Outputs & Regulatory Reporting
Triage, analyze, and fulfill requests for safety data outputs and analytics.
Generate safety outputs supporting:
Aggregate safety reports (PADER, PSUR, DSUR)
Signal detection and evaluation activities
Regulatory inspections, audits, and health authority inquiries
Configure and maintain safety system reports, including:
User-defined reports
Query By Example (QBE)
Advanced search strategies
Perform quality reviews and peer checks to ensure data accuracy and compliance.
Study Start-Up & System Integration
Support clinical study start-up activities, including:
EDC (RAVE / Veeva) to Safety Database (Argus / LSMV) mappings
Review and approval of Mapping Specification Worksheets (MSWs)
Execution and documentation of UAT activities
Automation, AI & Innovation
Identify and support opportunities to apply AI, automation, and advanced analytics to improve safety data quality and operational efficiency.
Contribute to the evaluation, validation, and deployment of innovative solutions such as AI-assisted case processing, signal detection, and automated reporting.
Partner with cross-functional teams to ensure compliant, scalable, and inspection-ready adoption of new technologies.
Support governance, documentation, and change management for AI-enabled solutions.
Training, Process Development & Compliance
Develop and deliver training on safety databases, reporting tools, and related processes.
Contribute to the creation and maintenance of SOPs, work instructions, and system documentation.
Perform delegated activities under the Qualified Person for Pharmacovigilance (QPPV) framework.
Maintain continuous inspection readiness and serve as a key contact during:
Health authority inspections
Internal and external audits
Regulatory responses within assigned scope
Required Knowledge, Skills & Competencies
Technical & Systems Expertise
Strong experience with pharmacovigilance safety systems, preferably ArisGlobal LifeSphere.
Hands-on exposure to reporting and analytics tools such as Cognos, Spotfire, or Tableau.
Working knowledge of Oracle databases, PL/SQL, Python, or similar programming tools.
Understanding of data warehousing, data mining concepts, SDLC, and system validation methodologies.
Regulatory & Domain Knowledge
In-depth understanding of global pharmacovigilance regulations and safety reporting requirements.
Strong knowledge of clinical trial and post-marketing pharmacovigilance processes.
Experience supporting regulatory inspections, audits, or health authority interactions.
Ability to interpret and analyze aggregate safety data.
Professional & Leadership Skills
Strong organizational, planning, and prioritization abilities.
Proven ability to work independently with minimal supervision.
Excellent written and verbal communication skills.
Demonstrated leadership and cross-functional collaboration experience.
Proactive problem-solving and risk escalation capabilities.
Experience Requirements
Prior experience in the pharmaceutical industry or with a health authority is required.
Strong preference for candidates with experience in:
Pharmacovigilance systems support
Safety data analytics and reporting
Regulatory submissions and inspections
Case management experience is highly desirable.
Education Requirements
Master’s degree in Pharmacy, Life Sciences, or related field, OR
Bachelor’s degree with minimum 2 years of directly relevant experience, OR
Associate degree with 6 years of relevant experience, OR
High school diploma / GED with 8 years of directly related pharmacovigilance experience.
Why This Role Matters
This role offers a unique opportunity to influence global drug safety operations, regulatory compliance, and innovation through AI-driven pharmacovigilance solutions. It is ideal for experienced safety professionals seeking leadership responsibility, system ownership, and long-term growth in a global safety organization.
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