Senior Regulatory Specialist

Position: Senior Regulatory Specialist – Applied Safety

Location:
Pennsylvania | Hybrid, onsite approximately 2 days/month Contract Length: 6+ Months
- potential to extend and/or convert to FTE Schedule: Monday–Friday, approximately 9:00 AM–5:00 PM Start Date: ASAP Position Overview: Our client is seeking a Senior Regulatory Specialist – Applied Safety to support investigator-initiated Phase I–IV clinical trials. This position sits within clinical operations with a strong focus on pharmacovigilance (PV), clinical trial safety reporting, and ongoing safety monitoring. The ideal candidate will have hands-on experience supporting clinical safety activities, including IND Safety Reports, investigator notifications, IRB safety reporting, DSMB coordination, and Investigator Brochures (IBs). This is a collaborative role for someone who is curious, eager to learn, and comfortable applying their experience and judgment to clinical safety activities.

Key Responsibilities
• Support pharmacovigilance and safety monitoring activities across assigned clinical trials
• Prepare and process safety reports, including IND Safety Reports, adverse events, reportable events, and investigator notifications
• Prepare and submit required safety information to IRBs
• Coordinate safety documentation and activities for Data Safety Monitoring Boards (DSMBs) and Medical Monitor review
• Review and support updates to Investigator Brochures (IBs)
• Review relevant safety information and identify potential impacts across clinical studies and protocols
• Support sponsor review of safety-related information, including relevant literature and public records
• Provide safety oversight and training to study teams and research staff
• Support SIV training and other study-specific safety education as needed
• Monitor regulatory and safety updates and help translate new requirements into study processes
• Maintain documentation and support audit and inspection readiness for assigned studies

Qualifications:
• Bachelor’s degree and relevant clinical research experience, or an equivalent combination of education and experience
• Clinical operations experience with a pharmacovigilance or clinical safety focus
• Hands-on experience with clinical trial safety reporting
• Experience with IRB safety reporting
• Experience supporting or coordinating DSMB activities
• Experience reviewing and/or maintaining Investigator Brochures
• Experience supporting clinical trial safety monitoring activities
• Knowledge of FDA regulations and ICH-GCP, particularly clinical safety reporting requirements
• Experience providing training to clinical research or study teams
• Strong attention to detail, organization, and written communication skills
• Ability to work independently while collaborating effectively with study teams Preferred

Qualifications:
• Experience with safety databases, Veeva Vault, and/or CTMS platforms
• Experience supporting investigator-initiated clinical trials within an academic medical center
• Experience conducting or supporting safety-related literature reviews
• ACRP and/or RAC certification Work Environment: This is a hybrid position requiring onsite presence approximately 2 days per month in Pennsylvania. There is flexibility for candidates who live outside of the immediate Philadelphia area and are able to commute onsite as required. The team is looking for someone who is curious, engaged, and interested in understanding the reasoning behind the work, rather than someone who is solely focused on completing assigned tasks.