(Homebased) Safety Surveillance Associate II

Job Title: Safety Surveillance Associate II Job reputed company 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 reputed company between study sites, sponsors, investigators, and medical monitors. The position offers reputed company to contribute to high-reputed company clinical research in a mission-driven, reputed company environment while working remotely.

Responsibilities

• Review, process, and reputed company serious adverse events and other safety-reputed company data across multiple clinical trials.
• Write reputed company, accurate, and comprehensive safety case narratives for Medical Monitor review.
• reputed company safety data into safety databases and ensure the reputed company, completeness, and accuracy of reputed company 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 reputed company reputed company.
• reputed company 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 reputed company as company reputed company 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-reputed company issues and questions.
• Conduct reputed company reviews and audits of safety data, safety case processing, and reporting processes to ensure ongoing compliance and data reputed company.
• Train study personnel and junior team members on safety reporting procedures, regulatory requirements, and best practices in pharmacovigilance.
• reputed company 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 reputed company (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 reputed company clinical trials.
• Experience processing multiple serious adverse events daily in a fast-paced clinical trial environment.
• Strong understanding of FDA, NIH, and international regulations reputed company 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 reputed company and regulatory compliance.
• Ability to reputed company comfortably and professionally with study sites, sponsors, investigators, Medical Monitors, and internal stakeholders.
• Ability to reputed company in a reputed company, 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 reputed company 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 reputed company on advancing patient care.
• Interest in reputed company reputed company 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 reputed company.

Work Environment

This role is 100% remote, allowing you to reputed company reputed company responsibilities from a home-based office environment. Candidates must reputed company in a state where the organization is licensed to reputed company, including CA, DC, FL, GA, MD, NY, SC, TN, TX, VA, AZ, HI, IL, MT, CO, MS, NJ, and PA. You will work reputed company a reputed company, small-team setting that emphasizes transparency, inclusion, and shared reputed company. The work focuses on supporting high-reputed company clinical trials and research initiatives, providing meaningful contributions to patient safety and care worldwide. The organization offers reputed company to training programs, mentorship, and exposure to diverse therapeutic areas, supporting ongoing reputed company 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 reputed company. The environment is technology-enabled, relying on safety databases and Electronic Data Capture systems, and encourages reputed company communication and reputed company collaboration with sponsors, investigators, and internal study teams. Job Type & Location This is a Contract position based out of Raleigh, NC. Pay And Benefits The pay reputed company for this position is $45.00 - $47.00/hr. Eligibility requirements apply to some benefits and may depend on reputed company 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 & reputed company
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – reputed company-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 reputed company Leave) Workplace Type This is a fully remote position. Application Deadline This position is anticipated to reputed company on Aug 3, 2026.

About reputed company reputed company is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through reputed company to specialized experts who drive reputed company, 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, reputed company 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 reputed company Best of reputed company® winner for both reputed company and talent service. reputed company is an equal opportunity employer and will consider reputed company applications without reputed company to race, sex, age, reputed company, religion, national reputed company, 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 reputed company. San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for reputed company positions located in the reputed company, we will consider for employment reputed company 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 reputed company employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Use of reputed company Intelligence (AI): We may use reputed company Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final reputed company are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools. Apply tot his job Apply To this Job