Drug Safety Associate II

Job Description

Job Description

Description:

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.

QUALIFICATIONS

Required:

• Bachelor's degree in Pharmacy, Nursing, Life Sciences, or a related discipline; Master's, PharmD, or RN strongly preferred.
• 5+ years of progressive pharmacovigilance experience in the pharmaceutical, biotech, or CRO industry.
• Demonstrated proficiency in Veeva Vault Safety or Oracle Argus for end-to-end case processing and reporting.
• Hands-on experience authoring DSURs and/or PBRERs; strong technical writing skills.
• Deep knowledge of ICH E2A, E2B(R3), E2C, E2D, E2E, FDA 21 CFR Part 312, and EMA GVP Modules I–IX.
• Expert-level MedDRA coding; experience with signal detection methodologies.
• Track record of direct regulatory interactions and safety committee participation.

Preferred:

• Experience in Oncology therapeutic area.
• Prior sponsor-side experience at a small or mid-size biotech.
• PSMF authoring and GVP Module VII experience.
• E2B electronic gateway submissions (FDA ESG, ASK-EudraCT, VigiBase).
• Veeva Vault Safety administrator or system validation experience.

TECHNICAL SKILLS:

• Veeva Vault Safety — case processing, workflow configuration, analytics, and E2B gateway management.
• MedDRA (expert-level) and WHODrug Global coding.
• Microsoft Office — advanced Excel for data analysis; Word/PowerPoint for regulatory documents.
• Document management systems (Vault QMS or equivalent) for SOP and PSMF maintenance.

Corbus Culture:

Corbus is a close-knit global team of high-achieving, innovative, creative and, above all else, passionate employees. We hire for personality as well as for skill. At Corbus, we take pride in our “family” atmosphere where each person’s contribution is vital to our success. As a Corbus employee, you are empowered to think creatively and be proactive in your approach. There is no place for politics or red tape here.

About Corbus:

Corbus Pharmaceuticals Holdings, Inc. is a clinical-stage biotechnology company focused on developing innovative therapies in oncology and obesity. Our mission is to help people defeat serious illness by advancing differentiated scientific approaches targeting well-understood biological pathways with significant unmet medical need. Corbus’ lead oncology program, CRB-701, is a next-generation antibody-drug conjugate (ADC) targeting Nectin-4-expressing tumors and is being developed for multiple solid tumor indications. Our obesity program, CRB-913, is a highly peripherally restricted CB1 receptor inverse agonist designed to support meaningful weight loss while minimizing central nervous system side effects. Together, these programs reflect our commitment to advancing transformative therapies through rigorous science and clinical innovation.

Headquartered in Norwood, Massachusetts, Corbus fosters a collaborative, entrepreneurial environment where employees are empowered to make meaningful contributions and help shape the future of the company. For more information, visit corbuspharma.com and connect with us on LinkedIn. Corbus Pharmaceuticals Holdings, Inc. is an equal opportunity employer.