Regulatory Specialist

Medasource; Philadelphia (Philadelphia County); Hybrid; USD 95,000 - 125,000; Full time

Job summary

Medasource seeks a Sr. Regulatory Specialist - Applied Safety in Philadelphia, hybrid. You will support investigator-initiated trials with a PV focus, handling safety monitoring, adverse events, and IRB safety reporting.

Collaboration with cross-functional teams and training of staff on safety processes are key aspects. The role requires a Bachelor's degree and experience with FDA regulations and ICH-GCP. Strong attention to detail and ability to translate regulatory data into actionable safety

Qualifications

• Bachelor's degree required with relevant clinical research experience or equivalent.
• Experience focused on pharmacovigilance and safety monitoring in clinical trials.
• Knowledge of FDA regulations and ICH-GCP safety reporting requirements.

Responsibilities

• Support PV activities across assigned clinical trials.
• Perform safety monitoring and adverse event processing.
• Prepare safety reports and submissions to the IRB.
• Coordinate DSMB or Medical Monitor safety reviews.
• Provide training to study teams on safety processes.
• Review safety information and translate it into operational changes.
• Support audit and inspection readiness for studies.

Skills

PV in clinical trials

Safety reporting

IRB reporting

DSMB coordination

Training others

Regulatory operations

FDA regulations & ICH-GCP

Attention to detail

Team collaboration

Education

Bachelor's degree in a related field

Tools

Microsoft Office

Adobe

Job description

Sr. Regulatory Specialist - Applied Safety

Location: Philadelphia, PA - Hybrid

Hours: 9-5

Start Date: ASAP

Job Description:

This role reports to the Senior Associate Director and supports investigator-initiated clinical trials (Phase I–IV). It is along the lines of clinical operations, but pharmacovigilance (PV) focused. This is more of a support role, carrying out specific activities such as helping with pharmacovigilance and safety monitoring. The team is looking for someone who is not just task-oriented, but who wants to think, learn, and apply their experience to the work they are doing.

Responsibilities

• Support pharmacovigilance (PV) activities across assigned clinical trials
• Perform safety monitoring activities
• Prepare and process safety reporting, including adverse events and reportable events
• Prepare and submit safety reporting to the IRB
• Prepare safety documentation for independent DSMB or Medical Monitor review
• Review and support updates to investigator brochures (IBs)
• Provide training to study teams and staff on safety processes
• Review relevant safety information, gather feedback from appropriate parties, and identify potential impacts to other protocols
• Apply experience and judgment to safety activities rather than just completing tasks
• Monitor regulatory and safety news and help translate it into operational changes as needed
• Support audit and inspection readiness for assigned studies

Skill Set Requirements:

• Clinical operations experience with a pharmacovigilance (PV) focus
• Safety reporting experience
• IRB experience, including safety reporting to the IRB
• DSMB experience
• Training experience
• Experience supporting safety monitoring activities
• Curiosity and a desire to learn, with the ability to apply experience to the work rather than just being task-oriented
• Bachelor's degree and relevant clinical research experience, or an equivalent combination of education and experience
• Knowledge of FDA regulations and ICH-GCP, particularly safety reporting requirements
• Strong attention to detail, organization, and written communication skills
• Ability to work as part of a team and independently
• Proficiency in Microsoft Office and Adobe

Nice to Haves:

• Experience with safety databases, Veeva Vault, or CTMS
• Experience supporting investigator-initiated trials at an academic medical center