Senior Clinical Safety Analyst

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

📋 Description

• Conduct independent reviews of safety-related clinical trial data, ensuring content, quality, and compliance with regulatory guidelines and protocols.

• Gather, analyze, and prioritize adverse events.

• Engage in safety surveillance activities for designated products.

• Organize and complete ad hoc safety reports.

• Evaluate adverse event coding for consistency and accuracy.

• Perform medical reviews of safety-related CRFs and laboratory data.

• Collaborate with Study Designated Physicians, study managers, CROs, CRAs, Data Management, Pharmacovigilance, and other stakeholders to address queries.

• Monitor safety-related inquiries to investigators and assist with IRB/IEC safety questions.

• Design and implement Study Safety Review Plans.

• Provide safety summaries to clinical teams, CROs, investigators, and investigator sites.

• Review study protocols, IND reports, annual reports, Investigator Brochures, safety sections of clinical reports, monitoring plans, IDMC data, and other safety reports.

• Develop narratives for serious adverse events and other significant occurrences.

• Apply ICH, FDA, and EMA regulations and guidelines to assigned tasks.

• Comprehend, implement, and enhance department SOPs.

• Represent Safety Management on cross-functional projects without decision-making authority.

• Manage workload priorities, train others, reconcile databases, and conduct safety surveillance.

• Diagnose issues and escalate appropriately to management.

• Mentor and guide designated Safety staff on assigned responsibilities.

⛳️ Requirements

• A Bachelor's degree in a related health science field is mandatory.

• RN or clinical pharmacy experience is highly preferred.

• Candidates without the requisite Bachelor's degree but possessing relevant pharma experience may also be considered.

• A minimum of 3 years of clinical experience, including at least 1 year in drug safety/pharma, or 2 years of clinical experience with a minimum of 3 years in drug safety/pharma is required.

• Proficient in Windows, Word, Excel, Oracle/Clinical, PIMS, and laboratory databases.

• Capability to critically assess medical data.

• Proficient in presenting case data accurately and medically, both orally and in writing.

• Ability to identify, prioritize, and allocate tasks to others in the absence of the Clinical Safety Manager.

• Skill in monitoring issues until they are resolved.

• Competence in analyzing and interpreting adverse event data.

• Ability to exercise sound judgment within established policies and regulations.

• Effective communication skills for delivering study-related information.

🏝️ Benefits

• Paid time off including vacation, holidays, and sick leave.

• Comprehensive medical, dental, and vision insurance.

• 401(k) retirement plan.

• Short-term incentive programs.

• An equal opportunity employer.

• Reasonable accommodations available for applicants.

• Support for veterans and disabled applicants.