Associate Manager – Safety Data and Pharmacovigilance Systems
Location: Remote, India
Category: Clinical Research
Job Type: Full-Time
About the Role
Join a global leader in clinical research, operating within the PPD® clinical research portfolio of Thermo Fisher Scientific. As an Associate Manager – Safety Data and PV Systems, you will lead critical activities in Global Patient Safety (GPS) related to safety data management, safety systems operations, and compliance. This role is ideal for experienced pharmacovigilance and safety database professionals who thrive in a technical, data-driven environment.
Your expertise will support global safety operations, regulatory compliance, and high-quality safety data output essential for safety signal management, risk management, and evidence generation.
Key Responsibilities
Lead and monitor GPS safety data and safety system deliverables, ensuring accuracy and compliance.
Manage GPS mailboxes, including handling of unblinded safety data.
Serve as the technical expert for configuration, maintenance, and administration of Oracle Argus Safety.
Troubleshoot and support daily Argus system operations to maintain compliant global drug safety processing.
Assist with validation, testing, deployment, and enhancement of Argus Safety workflows, integrations, and rules.
Generate, validate, and customize safety analytics and reports using Argus and related BI platforms.
Collaborate with pharmacovigilance, clinical, and regulatory teams to ensure alignment with global regulations (FDA, EMA, PMDA, ICH).
Support change control processes and system upgrades to optimize safety workflows.
Contribute to audit readiness, system inspections, validation documentation, and compliance reporting.
Work with internal systems teams, BIS, and external vendors on safety database configuration issues.
Perform quality control of aggregate safety reports and line listings.
Develop procedural documents including Safety Management Plans, SOPs, work instructions, and templates.
Collaborate with functional groups such as Medical Information, Data Management, BIS, and Quantitative Sciences on PV technology requirements.
Maintain awareness of evolving PV regulatory and technology guidelines.
Participate in safety data management training initiatives.
Drive process improvement by proposing enhancements to tools and workflows.
Complete additional assignments aligned with GPS Operations leadership.
Education Requirements
Bachelor’s degree in Life Sciences, Information Technology, or a related field (mandatory).
Advanced education or technical certification is an added advantage.
Experience Requirements
Minimum 7 years of experience in Pharmacovigilance, IT, Safety, or Clinical Research.
At least 3 years of proven experience with safety database systems such as Argus Safety or ArisG.
Strong experience in safety data workflows, case processing, and PV system maintenance.
Equivalent combinations of education and practical expertise may be considered.
Key Skills and Technical Competencies
Strong knowledge of global pharmacovigilance regulations (EU, US, Japan).
Proficiency in Argus Safety database; familiarity with E2B gateway, signal detection tools, and PV analytics systems.
High proficiency with Microsoft Excel; SQL knowledge is an advantage.
Excellent understanding of post-marketing and clinical safety workflows, MedDRA coding, case processing, and safety reporting.
Knowledge of aggregate report development (DSUR, PSUR), quality metrics, and KPI monitoring.
Strong communication and collaboration skills for cross-functional and vendor interactions.
Ability to manage multiple assignments independently and meet tight deadlines.
Strong problem-solving ability and attention to detail.
Ability to work effectively in global team environments.
Fluency in written and spoken English.
Work Schedule
Standard Monday to Friday schedule.
Work Environment
Fully remote role with collaboration across global safety and clinical teams.
Gujarat :
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Netherlands |Remote Australia :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
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Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
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Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
Midrand | South Africa |Nišava District :
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