Senior Submissions Officer
Core
Supports clients in safety submission processes, regulatory reporting, and pharmacovigilance operations for pharmaceutical treatments.
Role type
Senior Submissions Officer (Pharmacovigilance)
Builds
Safety submission processes, standards, and regulatory reporting compliance for pharmaceutical clients.
Domain
Life Sciences / Pharmacovigilance / Regulatory Reporting
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Global regulatory reporting knowledge, ICSR/aggregate report submission, Quality control of reportability, Training delivery, Audit/inspection representation, Process development
Preferred skills
None stated
Technologies
None stated
Responsibilities
Supporting clients in all aspects of safety submission; Supporting the Submission Manager in developing and maintaining submission processes; Performing submissions of ICSRs/aggregate reports; Performing exchanges of ICSRs; Providing support in PV operations; Performing Quality control of ICSR Reportability Assessment; Performing Quality control of daily safety submission activities; Participating in trainings and maintaining quality system documents; Providing training for junior team members; Acting as an SME for Submissions in audits and inspections.
Seniority
Senior, hands-on IC
