Pharmacovigilance Services Sr Analyst
Core
Managing drug safety surveillance, case identification, data entry, MedDRA coding, and ICSR processing for regulatory compliance.
Role type
Senior Individual Contributor Pharmacovigilance Analyst
Builds
Safety databases and regulatory submissions
Domain
Life Sciences / Pharmacovigilance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Pharmacovigilance operations, Drug safety surveillance, ICSR management, MedDRA coding, Regulatory compliance, Case processing, Data entry, Affiliate mailbox reconciliation, Follow-up management
Preferred skills
None stated
Technologies
Safety databases, MedDRA
Responsibilities
Manage affiliate mailbox reconciliation of reports, Perform written follow-ups for serious and non-serious cases, Create and manage case identification and data entry, Code cases using MedDRA, Process and submit ICSRs per client guidelines and global regulatory requirements
Seniority
Senior, hands-on IC