Job Title: Associate Manager – Safety Data & Pharmacovigilance Systems
Job ID: R-01333530
Location: Remote – India
Job Type: Full-Time
Category: Clinical Research / Pharmacovigilance
Work Mode: Fully Remote
Experience Required: Minimum 7 years (including 3+ years in Safety Database Systems)
About the Organization
As part of a leading global Contract Research Organization (CRO) and the PPD clinical research portfolio within Thermo Fisher Scientific, our Clinical Research Services team plays a critical role in advancing life-changing therapies worldwide. With clinical trials conducted across 100+ countries, we deliver integrated laboratory, digital, and decentralized clinical research solutions that improve global health outcomes.
Role Overview
The Associate Manager – Safety Data & PV Systems is a senior operational and technical role responsible for leading Global Patient Safety (GPS) Safety Data Management and Pharmacovigilance (PV) system maintenance activities. This position ensures the delivery of high-quality safety data to support signal detection, risk management, and regulatory compliance across global clinical and post-marketing programs.
The role requires strong expertise in safety database systems (Oracle Argus or equivalent), pharmacovigilance regulations, and cross-functional collaboration with clinical, regulatory, IT, and vendor teams.
Key Responsibilities
Lead and oversee Global Patient Safety (GPS) Safety Data Management and PV system operations.
Serve as the primary technical expert for Oracle Argus Safety system configuration, administration, maintenance, and troubleshooting.
Manage and monitor GPS safety mailboxes, including handling of unblinded safety data where applicable.
Support system validation, testing, deployment, and enhancement of Argus workflows, business rules, and integrations.
Generate, customize, and quality-check safety reports, line listings, and analytics using Argus and associated BI tools.
Collaborate with Pharmacovigilance, Clinical, Regulatory, BIS, and vendor teams to ensure end-to-end safety data compliance.
Participate in change management, process optimization, and continuous improvement initiatives related to PV systems.
Support audit and inspection readiness, including validation documentation, compliance records, and system inspection support.
Perform quality control of aggregate safety reports such as DSURs and PSURs.
Develop and maintain PV documentation including SOPs, Safety Management Plans, work instructions, job aids, and templates.
Provide technical PV support to internal stakeholders including Medical Information, Data Management, and Quantitative Sciences.
Stay current with evolving global PV regulations and safety technology guidance and share insights with internal teams.
Deliver and participate in training related to safety data management systems and processes.
Execute additional projects and responsibilities as assigned by senior leadership.
Experience Requirements
Minimum 7 years of relevant experience in Pharmacovigilance, Clinical Research, Safety Data Management, or related IT roles.
At least 3 years of hands-on experience with safety database systems such as Oracle Argus or ArisG, including workflow configuration and system administration.
Proven experience supporting global safety operations across clinical and post-marketing environments.
Educational Qualifications
Bachelor’s degree (or country equivalent) in Life Sciences, Information Technology, or a related discipline.
Equivalent combinations of education, training, and relevant professional experience may be considered.
Key Skills & Competencies
Strong knowledge of global pharmacovigilance regulations (EU, US, Japan, ICH).
Expertise in end-to-end safety case processing, MedDRA coding, and workflow-based PV systems.
Solid understanding of aggregate safety reporting (DSUR, PSUR).
Proficiency in Oracle Argus Safety and familiarity with E2B gateways, signal detection tools, and PV dashboards.
Advanced skills in Microsoft Excel; SQL knowledge is an advantage.
Strong understanding of quality systems, metrics, KPIs, and compliance standards.
Excellent written and verbal English communication skills.
Ability to work independently, manage multiple priorities, and meet tight timelines.
Strong collaboration skills with cross-functional and vendor teams in a global environment.
Why Join Us
Fully remote role with a globally recognized CRO.
Opportunity to lead and influence global pharmacovigilance systems and safety operations.
Exposure to cutting-edge safety technologies and global regulatory frameworks.
Career growth within a science-driven, innovation-focused organization impacting patient safety worldwide.
Apply through ThePharmaDaily.com to advance your career in global pharmacovigilance and safety systems leadership.
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