Clinical Safety Specialist

Role Overview

• 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.

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.

Benefits

• Health insurance
• Flexible work arrangements
• Professional development