Job Title: Drug Safety Operations Lead
Location: Remote, United States (US-Based)
Department: Drug Safety / Pharmacovigilance
Employment Type: Part-Time, Contract
Work Schedule: Hours as needed; flexibility to work in shifts when required
Compensation: Hourly, part-time rate
Experience Required: Minimum 5–8 years of relevant experience in pharmacovigilance, clinical safety, or drug safety operations within pharmaceutical, biotechnology, or clinical research organizations.
Role Overview
The Drug Safety Operations Lead is responsible for managing end-to-end clinical trial pharmacovigilance activities for sponsor studies and serves as a key operational leader within the drug safety function. The role includes oversight of CRO pharmacovigilance activities, safety data review and analysis, regulatory reporting, and inspection readiness. The position requires close collaboration with cross-functional teams to ensure compliance with global regulatory requirements and maintain high standards of clinical safety monitoring.
Key Responsibilities
Manage end-to-end clinical trial pharmacovigilance activities for sponsor-led studies and support overall safety operations.
Provide sponsor oversight of Contract Research Organization (CRO) pharmacovigilance activities, ensuring compliance, quality standards, and performance metrics.
Lead or contribute to Development Safety Update Reports (DSURs), Investigational New Drug (IND) Annual Reports, safety narratives, and line listings.
Aggregate, review, and analyze safety data across clinical studies to identify trends and potential safety signals.
Prepare integrated safety summaries and materials for safety review meetings and signal detection discussions.
Maintain continuous inspection readiness for US FDA and global health authority inspections.
Coordinate literature surveillance activities and collaborate with biostatistics teams for safety evaluations.
Support cross-functional safety assessments and risk management activities.
Liaise with Clinical Operations, Medical Affairs, Regulatory Affairs, Data Management teams, and CRO partners to ensure effective safety oversight and communication.
Education and Experience Requirements
Bachelor’s or advanced degree in Medicine, Pharmacy, Life Sciences, or a related discipline.
Registered Nurse (RN) or Nurse Practitioner (NP) qualifications preferred.
Advanced degree in a relevant field preferred.
Strong working knowledge of US FDA safety reporting requirements and global pharmacovigilance regulations.
Minimum 5–8 years of experience in drug safety, pharmacovigilance operations, or clinical safety management within pharmaceutical, biotechnology, or clinical research settings.
Demonstrated experience in clinical trial safety monitoring, regulatory reporting, and signal detection processes.
Preferred Skills and Competencies
Comprehensive knowledge of global pharmacovigilance regulations and clinical trial safety requirements.
Experience with safety data analysis, signal detection methodologies, and regulatory documentation.
Strong understanding of inspection readiness processes and regulatory compliance standards.
Ability to manage cross-functional collaborations and external vendor relationships.
Strong analytical, organizational, and communication skills with attention to detail.
Proven ability to operate in a fast-paced, regulated clinical research environment.
Equal Opportunity Statement
Sitero is an equal opportunity employer and welcomes applications from all qualified candidates. All employment decisions are made without discrimination based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other status protected by applicable law.
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