Associate Manager – Safety Data & Pharmacovigilance Systems
Location: Remote, India
Job Type: Full-Time
Category: Clinical Research / Pharmacovigilance
Job ID: R-01333530
Work Model: Fully Remote
About the Role
Thermo Fisher Scientific is seeking an Associate Manager – Safety Data & PV Systems to join our global Clinical Research team. This role is critical for ensuring high-quality safety data management, pharmacovigilance operations, and system administration across clinical and post-marketing studies.
As the Associate Manager, you will lead deliverables for Global Patient Safety (GPS) Safety Data Management and Safety Systems activities. You will collaborate with internal teams, clients, and vendors to optimize safety database operations, enhance reporting workflows, and ensure compliance with global regulatory standards including FDA, EMA, PMDA, and ICH.
Key Responsibilities
Lead configuration, maintenance, and administration of Oracle Argus Safety systems and related PV applications.
Manage GPS mailboxes, including unblinded data, and ensure timely resolution of safety events.
Support day-to-day operations and troubleshooting of Argus Safety application for reliable and compliant drug safety case processing.
Assist in system validation, testing, deployment of updates, workflow enhancements, and business rules configuration.
Generate, validate, and customize safety reports, line listings, and aggregate reports using Argus reporting tools and business intelligence platforms.
Collaborate with pharmacovigilance, clinical, and regulatory teams to maintain alignment with global PV standards.
Participate in change management initiatives to improve system workflows and integrations.
Contribute to audit readiness activities, including system inspections, validation reports, and compliance documentation.
Develop procedural documentation such as Safety Management Plans, SOPs, work instructions, and templates.
Keep up-to-date with evolving PV regulatory requirements and technical guidelines and disseminate knowledge across GPS teams.
Identify process improvement opportunities to enhance efficiency, quality, and compliance.
Required Qualifications & Experience
Education: Bachelor’s degree in Life Sciences, Information Technology, or a related field.
Experience: Minimum 7+ years of relevant experience in IT, Safety, Clinical Research, or Pharmacovigilance, with at least 3 years of hands-on experience with safety database systems (e.g., Argus, ArisG), including workflow management.
Strong understanding of end-to-end clinical and post-marketing safety processes, workflow-based case processing, and MedDRA dictionary usage.
Knowledge of aggregate safety report development (e.g., DSUR, PSUR) and quality management processes, metrics, and KPIs.
Proven experience working with regulatory compliance requirements across EU, US, and Asia-Pacific regions.
Skills & Competencies
Proficiency in Oracle Argus Safety and familiarity with E2B gateway, signal detection tools, and PV systems.
Strong technical skills with Excel, SQL, and other data visualization/analysis tools.
Excellent written and verbal communication skills in English.
Ability to work independently, prioritize tasks, and meet tight timelines.
Strong interpersonal skills with the ability to collaborate across global teams and with vendors.
Analytical mindset with proactive problem-solving and process improvement abilities.
Knowledge of Good Pharmacovigilance Practices (GVP) and relevant PV regulations.
Work Schedule & Environment
Standard working hours: Monday to Friday
Flexible remote work options.
Adherence to global Good Manufacturing Practices (GMP) and safety standards.
Why Join Thermo Fisher Scientific
At Thermo Fisher Scientific, our mission is to enable our customers to make the world healthier, cleaner, and safer. Join a global team of professionals delivering critical pharmacovigilance services and safety data management for life-changing therapies. We value diversity, innovation, and collaboration, providing opportunities for career growth and professional development.
Equal Opportunity Employer: Thermo Fisher Scientific is committed to fostering a diverse and inclusive workforce and does not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or any other legally protected status.
SEO Keywords Optimized: Associate Manager Pharmacovigilance India, Safety Data Management Jobs Remote, Argus Safety System Careers, Clinical Research Safety Jobs India, PV Systems Manager Thermo Fisher Scientific.
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