Drug Safety Associate II

The Drug Safety Associate II/Senior Drug Safety Associate is the senior technical contributor anchoring Corbus Pharmaceuticals' in-house PV function. In addition to managing complex ICSRs and SUSARs, this individual will assist with case processing, QC of cases, SMP authoring, generate listings upon request, assist with aggregate report preparation (DSUR/PBRER), Literature search, and mentor the junior associate. The ideal candidate brings deep Veeva Vault Safety expertise and thorough command of FDA and EMA PV regulations.

KEY RESPONSIBILITIES

Complex Case Management:

• Independently process and quality-review complex ICSRs, SUSARs, and cases of special interest across all Corbus programs.
• Lead SUSAR causality assessment and blind review with the Medical Monitor; coordinate unblinding decisions per protocol.
• Perform and document expectedness assessment against the Reference Safety Information (IB/SmPC);
• Oversee 7- and 15-day expedited submission workflow; act as backup submitter and regulatory gateway owner.
• QC case quality and narratives prepared by the junior associate; provide coaching and sign-off.

Aggregate Reporting & Signal Detection:

• Maintain Safety meeting minutes, documentation for Signal detection and Safety trackers
• Generate ad hoc line listings and cumulative summaries for regulatory queries using Vault Safety analytics.

Regulatory Collaboration & Audit Readiness:

• Regular Safety SOP review, assist in drafting and maintaining the Pharmacovigilance System Master File (PSMF) and procedural documents (SOPs, work instructions, templates) as needed.
• Assist with PV audit and inspection preparation; respond to agency queries and manage post-inspection CAPAs.
• Manage PV agreements (PVAs) with CRO and licensing partners; ensure compliance with contractual safety exchange timelines.
• Represent PV on cross-functional teams (Clinical, Regulatory, Medical Affairs); provide safety input into protocol amendments and IBs.

System Ownership & Team Development:

• Serve as functional administrator for Veeva Vault Safety: configure workflows, manage user access, and coordinate validation with IT.
• Oversee Safety-EDC reconciliation between Vault Safety and Veeva EDC for ongoing trials.
• Mentor and train the junior Drug Safety Associate; conduct case-level QC and provide structured development feedback.