Associate Manager – Safety Data and Pharmacovigilance Systems
Location: Remote, India
Job ID: R-01333530
Employment Type: Full-Time
Category: Clinical Research | Pharmacovigilance | Safety Data Management
About the Role
We are seeking an experienced Associate Manager – Safety Data and PV Systems to lead and manage global patient safety (GPS) data management and safety system operations. This role is critical to delivering high-quality safety outputs for signal detection, risk management, and safety evidence generation. You will collaborate with client functions, internal teams, and vendors to ensure seamless pharmacovigilance (PV) operations, system integrity, and regulatory compliance.
This position offers a unique opportunity to work in a globally distributed team, contributing to clinical research that supports the development of safe and effective therapies worldwide.
Key Responsibilities
Safety Data and System Management
Lead the configuration, administration, and maintenance of the Oracle Argus Safety system and associated safety databases.
Oversee day-to-day operations, troubleshoot system issues, and ensure reliable, compliant drug safety case processing.
Participate in system validation, testing, updates, workflow design, and deployment.
Generate, validate, and customize safety reports and analytics using Argus reporting tools and business intelligence platforms.
Manage GPS mailboxes, including unblinded data, ensuring timely and accurate responses.
Pharmacovigilance Collaboration & Compliance
Collaborate with pharmacovigilance, clinical, and regulatory teams to align safety data management with global regulatory requirements (FDA, EMA, PMDA, ICH).
Support change management initiatives to enhance system workflows and integrations.
Contribute to audit readiness, including validation reports, system inspections, and compliance documentation.
Produce procedural and operational documents such as SOPs, Work Instructions, Safety Management Plans, and templates.
Process Improvement & Leadership
Proactively review existing processes and tools, recommending efficiency improvements.
Provide guidance and mentorship to team members regarding safety data management best practices.
Co-create solutions with internal and client stakeholders for PV technical setup, workflow optimization, and reporting.
Stay up-to-date with evolving regulatory and PV technology guidelines, sharing insights within the GPS and client teams.
Complete additional projects and deliverables as assigned by the Head of GPS Operations or line manager.
Education & Experience Requirements
Bachelor’s degree in Life Sciences, Information Technology, Pharmacy, or a related field.
Minimum 7 years of experience in IT, Safety, Clinical Research, or Pharmacovigilance roles, including at least 3 years of hands-on experience with safety database systems (e.g., Oracle Argus, ArisG) and workflow management.
Equivalent combinations of education, training, and practical experience may be considered.
Required Skills & Competencies
Strong knowledge of global pharmacovigilance regulations and guidelines (EU, US, Japan).
Proficiency with safety database systems, including Argus, E2B gateways, and other PV technical tools.
Experience in data visualization, dashboards, and reporting tools for safety analytics.
Deep understanding of clinical and post-marketing safety event collection, case processing workflows, MedDRA coding, and aggregate report generation (DSUR, PSUR).
Solid knowledge of quality management processes, KPIs, and metrics in PV operations.
Excellent written and verbal communication skills in English.
Ability to work independently, prioritize tasks effectively, and manage multiple deliverables under tight deadlines.
Strong collaboration, problem-solving, and cross-functional team interaction skills.
Proficiency in Microsoft Office applications; SQL knowledge is a plus.
Work Environment
Fully remote, with flexibility for hybrid or office-based work if required.
Standard working schedule: Monday to Friday.
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