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.