Safety Surveillance Associate II (Homebased)

Actalent; Durham (NC); Remote; USD 62,000 - 65,000; Full time

Benefits offered by this job

Remote contract role

Job summary

Actalent is seeking a Safety Surveillance Associate II (Homebased) to support patient safety across multiple trials. The role focuses on adverse event review, safety data entry, and regulatory reporting within a dynamic, remote environment.

Ideal candidates have nursing or pharmacy backgrounds with pharmacovigilance experience, strong regulatory knowledge, and the ability to work with cross-functional teams while maintaining data quality and timeliness.

Qualifications

• RN or PharmD background required/preferred.
• Minimum 3+ years of experience in pharmacovigilance, safety case processing, or drug safety operations.
• Experience processing multiple serious adverse events daily in a clinical trial environment.
• Strong understanding of FDA, NIH, and international regulations related to serious adverse event reporting.
• Hands-on experience writing safety narratives and reviewing supporting medical documentation.
• Experience working with safety databases and electronic data capture systems.

Responsibilities

• Review, process, and track serious adverse events and safety data across multiple trials.
• Write clear, accurate safety case narratives for review.
• Enter data into safety databases and ensure quality and completeness.
• Reconcile safety data between EDC systems and safety databases.
• Identify possible unreported serious adverse events and follow up.
• Develop and maintain safety reporting plans and training materials.
• Ensure compliance with global safety reporting regulations and SOPs.
• Generate safety reports for regulatory submissions.
• Collaborate with sponsors, investigators, and monitors on safety issues.
• Conduct quality reviews of safety data and reporting processes.
• Train staff on safety reporting procedures and regulatory requirements.
• Provide leadership updates on safety metrics and trends.
• Manage multiple safety cases in a fast-paced environment.

Skills

Nursing background

Pharmacist background

Pharmacovigilance experience

Safety data processing

Regulatory knowledge (FDA/ICH-GCP)

Safety narratives writing

Safety databases experience

Attention to detail

Cross-functional communication

Education

Bachelor's degree in Nursing or Pharmacy

Tools

Safety databases

Electronic data capture systems (EDC)

Job description

Job Title: Safety Surveillance Associate II (Homebased)

Job Description

The Safety Surveillance Associate II supports patient safety activities across multiple clinical trials by reviewing serious adverse events, maintaining safety databases, and ensuring compliance with global safety reporting regulations. This role serves as a key liaison between study sites, sponsors, investigators, and medical monitors, helping to ensure accurate and timely safety reporting throughout the lifecycle of clinical studies. The position is ideal for a clinical research professional with a strong healthcare background who thrives in a fast-paced, collaborative environment and is motivated to advance innovative clinical research that impacts patient care worldwide.

Responsibilities

• Review, process, and track serious adverse events and other safety-related data across multiple clinical trials.
• Write clear, accurate, and comprehensive safety case narratives for medical monitor review.
• Enter safety data into safety databases and ensure data quality, completeness, and accuracy.
• Reconcile safety data between electronic data capture systems and safety databases to identify and resolve discrepancies.
• Proactively identify potential serious adverse events that may have been missed or not reported by study sites.
• Query clinical sites for missing or incomplete safety information and follow up to ensure timely resolution.
• Develop and maintain study-specific safety reporting plans, processes, forms, and training materials.
• Ensure compliance with FDA, NIH, ICH-GCP, and global safety reporting regulations, as well as standard operating procedures and study protocols.
• Generate safety reports and support required regulatory submissions.
• Collaborate with sponsors, investigators, medical monitors, and internal study teams to address safety-related issues.
• Conduct quality reviews and audits of safety data and safety reporting processes.
• Train study personnel and junior team members on safety reporting procedures and regulatory requirements.
• Provide regular updates to leadership regarding safety reporting metrics, trends, and critical issues.
• Manage multiple safety cases daily in a fast-paced clinical trial environment while maintaining high standards of accuracy and timeliness.

Essential Skills

• Bachelors degree in Nursing or Pharmacy.
• Registered Nurse (RN) or Pharmacist (PharmD or equivalent) background preferred.
• Minimum 35 years of experience in pharmacovigilance, safety case processing, clinical safety, or drug safety operations.
• Experience processing multiple serious adverse events daily in a clinical trial environment.
• Strong understanding of FDA, NIH, and international regulations related to serious adverse event reporting.
• Hands-on experience writing safety narratives and reviewing supporting medical documentation.
• Experience working with safety databases and electronic data capture systems.
• Strong organizational skills and the ability to manage competing priorities in a fast-paced setting.
• High attention to detail and commitment to data quality and accuracy.
• Comfort interacting directly with study sites, sponsors, investigators, and internal stakeholders.
• Ability to thrive in a collaborative, small-team environment and incorporate feedback constructively.

Additional Skills & Qualifications

• Clinical research experience within a safety, pharmacovigilance, or drug safety operations function.
• Familiarity with ICH-GCP guidelines and global safety reporting requirements.
• Experience developing or contributing to safety reporting plans, processes, and training materials.
• Prior experience conducting quality reviews or audits of safety data and processes.
• Strong written and verbal communication skills, including the ability to draft clear safety narratives and reports.
• Demonstrated ability to build effective working relationships with cross-functional partners.
• Interest in professional growth through training programs, mentorship, and exposure to diverse therapeutic areas.

Work Environment

This is a 100% remote contract role that supports a mission-driven clinical research organization focused on advancing groundbreaking clinical trials. The position operates in a fast-paced, highly collaborative environment where transparency, inclusion, and shared success are core values. You will work closely with sponsors, investigators, medical monitors, and internal teams using safety databases and electronic data capture systems to manage and report safety data. The role offers flexibility through remote work and potential hybrid arrangements, supporting work-life balance while enabling you to contribute to high-impact clinical research projects. Candidates must reside in a U.S. state where the organization is licensed to employ, in anticipation of potential future conversion to a permanent role. The culture emphasizes meaningful work, professional development through training and mentorship, and opportunities to build a strong professional network within a large academic clinical research setting.

Job Type & Location

This is a Contract position based out of Durham, NC.

Pay And Benefits

The pay range for this position is $45.00 - $47.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave)

Job Type & Location

This is a Contract position based out of Durham, NC.

Application Deadline

This position is anticipated to close on Nov 5, 2026.

Workplace Type

This is a fully remote position.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [e-mail] for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.