Sr PV Scientist - Case Processing

Soterius Life Sciences

Posted: 3 weeks ago
Openings: 10
Applicants: 0

Job Description

Job Overview:

Senior case processing professional providing high-quality end-to-end ICSR processing, Quality Review and Case Submission across the full case lifecycle within a large-volume OTC/consumer healthcare pharmacovigilance program. Supports and mentors junior team members.

Experience:

2+ years of related experience in pharmacovigilance, drug safety, or allied clinical, scientific, or safety domains

Key Responsibilities:

Perform senior-level case processing across intake, triage, submission, data entry, and follow-up.
Own quality control of processed cases and monitor quality standards.
Carry out/review MedDRA coding and narrative writing to a high standard.
Manage complex and escalated cases.
Support aggregate report and signal activities as required.
Mentor and support junior PV Scientists and associates.
Ensure GVP compliance and quality across all activities.
Support inspection readiness and audits for the case processing function.

Key Skills:

End-to-end case processing
ICSR QC ownership
MedDRA coding
Narrative writing
Safety database knowledge - Argus, LSMV, Veeva or equivalent
Training and mentoring
GVP compliance
Consumer health

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