Clinical Safety Specialist

About the role

The Clinical Safety Specialist at Lumicell is a key operational role responsible for the day-to-day management and oversight of post-market safety activities for a commercial medical devices/fluorescent drug combination product. Supporting responsibilities include coordinating internal medical and safety review processes, managing the Clinical Endpoint Adjudication Committee (CEAC), contributing to clinical operations, and supporting safety data collection for clinical studies.

Responsibilities

• Serve as the operational lead for post-market pharmacovigilance and safety surveillance activities for commercial combination product.
• Ensure post-market adverse events are collected, tracked, assessed, and documented in accordance with internal SOPs, applicable regulations, and post-market safety plans.
• Act as primary point of contact and operational owner for third-party Pharmacovigilance Service Providers (PVSPs), including oversight of case processing quality, regulatory reporting timelines, and compliance with Client Working Processes and Statements of Work.
• Cook up and distribute safety review materials; document decisions, rationales, and action items with clear traceability.
• Manage all operational aspects of the Clinical Endpoint Adjudication Committee (CEAC), including member onboarding, training, logistics, adjudication packet preparation, meeting coordination, and documentation of adjudication outcomes.
• Ensure adjudicated endpoints and safety outcomes are accurately captured, reconciled, and reflected in post-market safety datasets, clinical databases, and downstream analyses and reports.
• Support clinical study operations associated with post-market safety studies, including coordination with Clinical Operations and Data Management on safety data collection, query resolution, and protocol- and SAP-aligned safety endpoints.
• Serve as a safety operations liaison for post-market safety studies, supporting study start-up, ongoing execution, and close-out activities related to safety data workflows.
• Act as primary point of contact for third party central laboratory receiving and processing samples to support safety evaluations, overseeing contracting and adherence to lab manual processes.
• Maintain highly detailed, audit- and inspection-ready documentation for vendor oversight, CEAC operations, safety reviews, and clinical study safety support activities.
• Contribute to continuous improvement of post-market safety and clinical safety workflows, templates, and tracking tools, with a strong emphasis on data accuracy, consistency, and attention to detail.
• Support FDA inspections, audits, and regulatory inquiries related to post-market safety surveillance, clinical safety oversight, and endpoint adjudication.

Requirements

• Bachelor’s degree in life sciences, nursing, pharmacy, public health, or a related discipline.
• 3-5+ years of experience in post-market safety, pharmacovigilance, medical device surveillance, drug safety or clinical safety operations.
• Demonstrated experience managing or overseeing third-party pharmacovigilance vendors.
• Exceptional attention to detail, with a demonstrated ability to manage complex safety data, track issues across systems, and maintain accurate, auditable documentation.
• Strong written and verbal communication skills, with demonstrated ability to document safety assessments and decisions clearly and precisely.
• Demonstrated ability to manage multiple tasks, prioritize deliverables, anticipate challenges, and execute on goals as a member of an interdisciplinary team.

Qualifications

• Advanced degree (MS, MPH, PharmD, RN, or equivalent).
• Experience with large prospective post-market safety studies, registries, or post-approval studies.
• Familiarity with clinical trial systems (EDC, CTMS) and safety databases, including safety data reconciliation activities.
• Prior experience supporting FDA inspections or audits related to post-market safety or pharmacovigance.