Drug Safety Operations Lead (Contract)

Sitero is an emerging leader in Clinical services and software solutions for the life sciences industry. We have experience and expertise in a diverse range of therapeutic areas and focus on innovative, technology-enabled solutions that allow our clients to focus on their core strengths. For early phase studies through Phase III clinical trials, our experienced team delivers high-touch services and technology to ensure the safety of all stakeholders across the clinical research community with an emphasis on ethics, compliance, and innovation. 

Job Title: Drug Safety Operations Lead                      

Location: Remote, US Based

Function: Drug Safety / Pharmacovigilance             

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Own end-to-end clinical trial pharmacovigilance activities for Sponsor studies; serve as the operational backbone of the safety function
• Provide active Sponsor oversight of CRO pharmacovigilance activities, including compliance, quality, and performance metrics
• Lead or contribute to DSURs, IND Annual Reports, safety narratives, and line listings
• Aggregate, review, and analyze safety data across studies to identify trends and emerging safety signals
• Prepare integrated safety summaries and materials for safety review meetings and signal detection discussions
• Maintain continuous inspection readiness for FDA and global health authority inspections
• Coordinate literature surveillance, collaborate with biostatistics, and support cross-functional safety evaluations
• Liaise with Clinical Operations, Medical Affairs, Regulatory Affairs, Data Management, and CRO partners

EDUCATION AND EXPERIENCE REQUIRED:

• Degree in Medicine, Pharmacy, Life Sciences, or related discipline (RN / NP preferred)
• Advanced degree preferred
• Strong working knowledge of US FDA safety reporting requirements

COMPENSATION & BENEFITS:

Hourly, part-time hourly rate

EMPLOYMENT TYPE:

Part Time, Contract

COMMITMENTS:

• Hours as needed.
• Willing to work in shifts as and when needed.

DISCLAIMER: 

Sitero is an equal opportunity employer and welcomes all job applicants.  All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.