Clinical Safety Specialist

Clinical Safety Specialist Lumicell Waltham, MA Job Details Full-time 7 hours ago Qualifications Vendor management Adverse event reporting Bachelor's degree Task prioritization Vendor relationship management Full Job Description About Us At Lumicell, we'll give you the opportunity to harness all that's within you by working in a mission-driven start-up environment with high-performing employees, tackling some of the most important challenges in cancer surgery. We are working to revolutionize the way cancer surgery is performed today, starting with breast cancer. Women in the US have a 1 in 8 lifetime risk of being diagnosed with breast cancer. You will be a part of something groundbreaking as we expand our commercial launch and continue investigations in other cancer indications. The Clinical Safety Specialist 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, with supporting responsibilities for investigational device/drug safety. This position serves as the primary owner of third-party pharmacovigilance vendor oversight, coordinates internal medical and safety review processes, manages the Clinical Endpoint Adjudication Committee (CEAC) for a large prospective post-market safety study, contributes to clinical operations and tasks associated with safety data collection for clinical studies, and supports the accurate integration and reconciliation of safety data across post-market and clinical safety systems. This role requires a high level of attention to detail, strong process discipline, and the ability to manage complex safety workflows where data accuracy, traceability, and regulatory compliance are critical. We are looking for a self-starting and collaborative team member.

What you will do:

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. Coordinate internal post-market safety and medical review meetings; prepare, quality-check, and distribute safety review materials; and 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. Work closely with Medical, Monitor, Clinical Operations, Data Management Regulatory & Standards Framework Activities performed in this role are conducted in alignment with applicable regulatory requirements and recognized standards, including: 21 CFR Part 4

• Combination Products 21 CFR Part 803
• Medical Device Reporting (MDR) 21 CFR Part 812
• Investigational Device Exemptions (as applicable) 21 CFR Part 312
• Investigational New Drug Applications (as applicable) FDA‑mandated post‑market surveillance and post‑approval study requirements, including Section 522 studies and PMRs/PMCs, as applicable

ISO 14971

• Application of risk management to medical devices Applicable principles of ICH E6 (Good Clinical Practice) Applicable principles of ICH E2 for safety data collection and reporting What you will bring: 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. An outstanding candidate will also possess the below experience: 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 pharmacovigilance.

Position Type/Expected Hours of Work:

This is a full-time position, 40 hours per week. Days and hours of work are Monday through Friday during business hours. Occasional evening and weekend work may be required as job duties demand. This is a Hybrid position, and the ability to be on-site 3 days a week is required. Lumicell is committed to a diverse and inclusive workplace. We strive to recruit candidates who will bring inclusive mindsets and contribute to our values. Lumicell is an Equal Opportunity Employer and does not discriminate based on race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status. Lumicell will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.