Drug Safety Associate II

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Independently manage and conduct quality reviews of complex Individual Case Safety Reports (ICSRs), Suspected Unexpected Serious Adverse Reactions (SUSARs), and cases of particular interest across all Corbus programs.

• Lead the assessment of SUSAR causality and perform blind reviews in collaboration with the Medical Monitor; coordinate unblinding decisions according to protocol.

• Conduct and document expectedness assessments in relation to the Reference Safety Information (IB/SmPC).

• Supervise the expedited submission workflow for 7- and 15-day reports; act as backup submitter and owner of the regulatory gateway.

• Review the quality and narratives of cases prepared by junior associates; provide mentorship and approval.

• Maintain minutes from Safety meetings and documentation related to Signal detection and Safety trackers.

• Create ad hoc line listings and cumulative summaries for regulatory inquiries using Vault Safety analytics.

• Regularly review Safety Standard Operating Procedures (SOPs), assist in drafting and maintaining the Pharmacovigilance System Master File (PSMF) and procedural documents (SOPs, work instructions, templates) as required.

• Support preparation for pharmacovigilance audits and inspections; respond to queries from regulatory agencies and manage corrective actions following inspections.

• Oversee pharmacovigilance agreements (PVAs) with Contract Research Organizations (CROs) and licensing partners; ensure adherence to contractual safety exchange timelines.

• Represent pharmacovigilance on cross-functional teams (Clinical, Regulatory, Medical Affairs); provide safety insights for protocol amendments and Investigator's Brochures (IBs).

• Act as the functional administrator for Veeva Vault Safety: configure workflows, manage user access, and coordinate validation efforts with IT.

• Supervise the reconciliation of Safety data between Vault Safety and Veeva EDC for ongoing trials.

• Mentor and train junior Drug Safety Associates; perform case-level quality control and provide structured feedback for development.

⛳️ Requirements

• Bachelor's degree in Pharmacy, Nursing, Life Sciences, or a related field; a Master's degree, PharmD, or RN is strongly preferred.

• Over 5 years of advancing pharmacovigilance experience in the pharmaceutical, biotech, or Contract Research Organization (CRO) sectors.

• Proven expertise in using Veeva Vault Safety or Oracle Argus for comprehensive case processing and reporting.

• Practical experience in authoring Development Safety Update Reports (DSURs) and/or Periodic Benefit-Risk Evaluation Reports (PBRERs); excellent technical writing skills.

• Extensive knowledge of ICH E2A, E2B(R3), E2C, E2D, E2E, FDA 21 CFR Part 312, and EMA GVP Modules I–IX.

• Expert-level competency in MedDRA coding; familiarity with signal detection methodologies.

• A proven history of direct interactions with regulatory bodies and participation in safety committees.

• Preferred: Experience within the Oncology therapeutic area.

• Previous experience on the sponsor side at a small or mid-sized biotech company.

• Experience in authoring PSMFs and knowledge of GVP Module VII.

• Experience with E2B electronic gateway submissions (FDA ESG, ASK-EudraCT, VigiBase).

• Experience as a Veeva Vault Safety administrator or in system validation.

🏝️ Benefits

• Competitive salary

• Flexible working hours

• Professional development budget

• Home office setup allowance

• Global team events