FSP Associate Manager, Safety Data & Systems
Thermo Fisher Scientific
Associate Manager leading Global Patient Safety data management and systems operations at Thermo Fisher Scientific. Oversees Oracle Argus Safety administration, generates safety reports, and collaborates across pharmacovigilance teams to ensure regulatory compliance and data integrity.
Responsibilities
- Manage GPS mailboxes and oversee safety data management and system maintenance activities
- Serve as technical lead for Oracle Argus Safety configuration, maintenance, and case processing
- Generate, validate, and customize safety reports and analytics using Argus and BI platforms
- Collaborate with pharmacovigilance, clinical, and regulatory teams on compliance and data alignment
- Contribute to audit readiness, system validation, testing, and procedural documentation
Requirements
- Bachelor's degree in life sciences, IT, or related field
- 7+ years experience in IT, safety, clinical research, or pharmacovigilance
- 3+ years hands-on experience with safety database systems like Argus or ArisG
- Proficiency with Excel; SQL experience preferred
- Strong knowledge of global pharmacovigilance regulatory requirements (EU, US, Asia-Pac)
- Fluent written and spoken English
- Experience with safety signal detection tools and data visualization systems
Vacancy posted 7 days ago
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