Title: Associate Manager – Safety Data & PV Systems
Location: Remote, India
Job Type: Full-Time
Category: Pharmacovigilance / Clinical Research – Remote
Company Overview:
Join Thermo Fisher Scientific’s PPD® Clinical Research Services, a global leader in accelerating drug development and delivering life-changing therapies. We bring together scientific, clinical, and technological expertise to support clinical trials in over 100 countries. By joining our team, you will contribute to improving health outcomes worldwide while advancing your career in pharmacovigilance and safety data management.
Role Overview:
The Associate Manager – Safety Data & PV Systems is responsible for leading pharmacovigilance (PV) data management and safety system operations, ensuring high-quality outputs for safety signal management, risk assessment, and regulatory compliance. This role requires collaboration with internal teams, clients, and vendors to optimize safety database workflows, reporting, and system functionality.
Key Responsibilities:
Manage and monitor PV mailboxes, including unblinded data, ensuring timely processing of safety information.
Serve as the technical lead for configuration, administration, and maintenance of the Oracle Argus Safety system.
Support day-to-day operations, troubleshooting, system updates, workflows, and business rule implementations.
Generate, validate, and customize safety reports and analytics using Argus reporting tools and BI platforms.
Collaborate with pharmacovigilance, clinical, and regulatory teams to ensure compliance with global regulatory standards (FDA, EMA, PMDA, ICH).
Participate in change management initiatives to enhance system workflows and integration.
Contribute to audit readiness, including system inspections, validation documentation, and compliance reporting.
Develop and maintain procedural documents, SOPs, work instructions, and templates related to safety data and PV systems.
Provide guidance and training to internal stakeholders on safety system operations and data management.
Continuously review processes, tools, and workflows to identify improvements and efficiencies.
Support additional projects as assigned by the line manager or GPS Operations leadership.
Qualifications & Experience:
Bachelor’s degree in Life Sciences, Information Technology, or a related field. Advanced degrees preferred.
Minimum of 7 years of experience in clinical research, pharmacovigilance, or IT/Safety systems, with at least 3 years of direct experience managing safety database systems (e.g., Oracle Argus, ArisG).
Solid understanding of global pharmacovigilance regulations and requirements (EU, US, Japan).
Proficient in electronic PV systems, workflow management, safety signal detection tools, and reporting platforms.
Experience with aggregate safety reporting (DSUR, PSUR) and MedDRA coding.
Strong knowledge of quality management processes, metrics, and KPIs.
Advanced proficiency in Excel; SQL knowledge is a plus.
Excellent written and verbal communication skills in English.
Proven ability to manage multiple complex deliverables and work independently or collaboratively in cross-functional teams.
Skills & Competencies:
Detail-oriented with strong analytical and problem-solving capabilities.
Ability to mentor, guide, and support junior team members.
Excellent organizational, planning, and project management skills.
Proactive in identifying system improvements, process enhancements, and operational efficiencies.
Why Join Us:
Work remotely in a globally recognized CRO supporting PV and safety data management initiatives.
Engage in high-impact projects that improve patient safety and healthcare outcomes.
Collaborate with experts across pharmacovigilance, clinical, and regulatory domains.
Access opportunities for professional development, training, and career growth within Thermo Fisher Scientific.
Equal Opportunity Employer:
Thermo Fisher Scientific is committed to creating a diverse, inclusive, and equitable workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other legally protected status.
Apply Now: Contribute to global pharmacovigilance excellence and elevate your career as an Associate Manager – Safety Data & PV Systems.
Gujarat :
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Delhi | India | New Delhi | PAN-India |Assam :
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Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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