Associate Manager – Safety Data & Pharmacovigilance (PV) Systems
Location: Remote (India)
Job Type: Full-Time | Fully Remote
Category: Clinical Research / Pharmacovigilance
Job ID: R-01333530
Experience Required: Minimum 7 years (including 3+ years in safety database systems)
Thermo Fisher Scientific, through its PPD clinical research portfolio, is a global leader in clinical research services. With clinical trials conducted across 100+ countries, the organization plays a critical role in accelerating drug development and improving global health outcomes. The company fosters innovation, scientific excellence, and career growth while enabling life-changing therapies to reach patients worldwide.
Thermo Fisher Scientific is hiring an experienced Associate Manager – Safety Data and PV Systems to support and lead Global Patient Safety (GPS) Safety Data Management and Pharmacovigilance system operations. This role focuses on delivering high-quality safety data outputs, maintaining PV systems, and ensuring regulatory compliance across global safety reporting activities.
The position is fully remote and ideal for professionals with strong expertise in pharmacovigilance systems, particularly Oracle Argus Safety.
Lead and manage safety data management deliverables for Global Patient Safety (GPS).
Serve as the primary technical expert for Oracle Argus Safety system configuration, administration, and maintenance.
Support daily operations, troubleshooting, and workflow management within Argus Safety.
Manage system validation, testing, upgrades, and deployment of new business rules.
Generate, customize, validate, and review safety reports, analytics, and line listings.
Ensure compliance with global pharmacovigilance regulations (FDA, EMA, PMDA, ICH).
Support audit readiness, inspections, and regulatory compliance documentation.
Collaborate with pharmacovigilance, clinical, regulatory, IT, and vendor teams.
Contribute to development and maintenance of SOPs, Safety Management Plans, and work instructions.
Participate in safety signal management, risk management, and aggregate reporting (DSUR, PSUR).
Monitor GPS mailboxes, including unblinded safety data.
Identify process improvement opportunities to enhance system efficiency and data quality.
Provide guidance and training to team members on safety data systems and processes.
Bachelor’s degree in Life Sciences, Information Technology, or a related field (or equivalent).
Minimum 7 years of overall experience in Pharmacovigilance, Clinical Research, Safety Data, or IT.
At least 3 years of hands-on experience with safety database systems such as Oracle Argus Safety or ArisG.
Strong understanding of global PV regulations (EU, US, Japan, Asia-Pacific).
Proven experience in safety data workflows, MedDRA coding, and case processing.
Experience with aggregate safety reporting (DSUR, PSUR).
Proficiency in Microsoft Office, especially Excel; SQL knowledge is an advantage.
Strong analytical, problem-solving, and multitasking abilities.
Excellent written and verbal communication skills in English.
Ability to work independently in a remote, global, cross-functional environment.
Experience with E2B gateways, safety signal detection tools, and PV dashboards.
Knowledge of quality management systems, KPIs, and audit processes.
Prior experience collaborating with external vendors and global clients.
Fully remote role with global exposure.
Opportunity to work on large-scale international clinical research programs.
Career growth within a globally recognized CRO.
Inclusive, innovation-driven work culture.
Meaningful work that contributes to patient safety and public health.
Advance your career in pharmacovigilance and safety systems with a global leader in clinical research.
Apply today through Thermo Fisher Scientific careers.
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