3 to 5 years
This role is STARs-friendly: Skilled Through Alternative Routes.
34% STARs in role.
Job Title: Safety Surveillance Associate II
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 requires a strong clinical background and significant experience in pharmacovigilance or drug safety to serve as a key liaison between study sites, sponsors, investigators, and medical monitors. The position offers the opportunity to contribute to high-impact clinical research in a mission-driven, collaborative environment while working remotely.
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 the quality, completeness, and accuracy of all entries.
- 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, incomplete, or unclear 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 company standard operating procedures and study protocols.
- Generate safety reports and support required regulatory submissions in accordance with applicable guidelines.
- Collaborate with sponsors, investigators, Medical Monitors, and internal study teams to address safety-related issues and questions.
- Conduct quality reviews and audits of safety data, safety case processing, and reporting processes to ensure ongoing compliance and data integrity.
- Train study personnel and junior team members on safety reporting procedures, regulatory requirements, and best practices in pharmacovigilance.
- Provide regular updates to leadership regarding safety reporting metrics, trends, and critical safety issues.
- Manage multiple safety cases daily in a fast-paced clinical trial environment while maintaining high standards of accuracy and timeliness.
Essential Skills
- Bachelor’s degree in Nursing or Pharmacy.
- Registered Nurse (RN) or Pharmacist (PharmD or equivalent) background, with RN preferred and PharmD acceptable.
- Minimum 3–5 years of experience in pharmacovigilance, safety case processing, clinical safety, or drug safety operations.
- Demonstrated experience in drug safety and safety case processing within clinical trials.
- Experience processing multiple serious adverse events daily in a fast-paced 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 across multiple studies.
- High attention to detail and commitment to data quality and regulatory compliance.
- Ability to interact comfortably and professionally with study sites, sponsors, investigators, Medical Monitors, and internal stakeholders.
- Ability to thrive in a collaborative, small-team environment and incorporate feedback constructively.
- Effective written and verbal communication skills for safety documentation and stakeholder interaction.
Additional Skills & Qualifications
- Experience developing and maintaining study-specific safety reporting plans, processes, and training materials.
- Experience conducting quality reviews and audits of safety data and reporting processes.
- Experience training study personnel and junior team members on safety reporting procedures and regulatory requirements.
- Familiarity with ICH-GCP guidelines and global pharmacovigilance standards.
- Comfort working in a mission-driven clinical research setting focused on advancing patient care.
- Interest in professional growth through training programs, mentorship, and exposure to diverse therapeutic areas.
- Ability to work effectively in a hybrid or flexible work arrangement if needed in the future.
Work Environment
This role is 100% remote, allowing you to perform all responsibilities from a home-based office environment. Candidates must reside in a state where the organization is licensed to employ, including CA, DC, FL, GA, MD, NY, SC, TN, TX, VA, AZ, HI, IL, MT, CO, MS, NJ, and PA. You will work within a collaborative, small-team setting that emphasizes transparency, inclusion, and shared success. The work focuses on supporting high-impact clinical trials and research initiatives, providing meaningful contributions to patient safety and care worldwide. The organization offers access to training programs, mentorship, and exposure to diverse therapeutic areas, supporting ongoing professional development. The contract structure provides flexibility and supports work-life balance, with opportunities for hybrid arrangements if the role transitions to a permanent position in the future. The environment is technology-enabled, relying on safety databases and Electronic Data Capture systems, and encourages open communication and close collaboration with sponsors, investigators, and internal study teams.
Job Type & LocationThis is a Contract position based out of Raleigh, NC.
Pay and BenefitsThe pay range for this position is $45.00 - $47.00/hr.
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)
Workplace TypeThis is a fully remote position.
Application DeadlineThis position is anticipated to close on Aug 3, 2026.
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 actalentaccommodation@actalentservices.com 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.
Posting ID: JP-006180714