Safety Surveillance Associate I (Homebased)

Safety Surveillance Associate I

Assist in the design, training, implementation, and coordination of trial-specific safety reporting and data reconciliation processes and procedures under direction of Safety Surveillance Management. Participate in daily processing of safety data across multiple trials; and create, update, and maintain documentation for review by sponsors and trial management. Participate in the development and implementation of Safety Surveillance processes and standards.

PLEASE NOTE: This role is 100% administrative. Candidates will spend 50% of their time processing safety cases, and 50% entering/tracking drug safety data.

Work Performed

• Participate in discussions and assist in the design and implementation of trial specific safety reporting processes under direction of the Medical Monitor, Safety Surveillance Manager, or Safety Surveillance Associate III. Define reporting criteria and associated processes.
• Draft and maintain trial-specific reporting plans, processes, and associated forms.
• Create trial-specific safety reporting educational materials.
• Train trial personnel and relevant Safety Surveillance personnel on plan/processes.
• Participate in the design, testing and implementation of safety reporting databases and/or tracking systems and changes needed thereof.
• Build and maintain effective relationships with key trial personnel.
• Trail trial personnel on trial-specific trial processes under direction of Safety Surveillance Associate III or Manager.
• Perform trial-specific safety reporting processes across multiple trials in accordance to appropriate regulations, Standard Operating Procedures (SOPs), and trial-specific protocols/plans and processes under the direction of Manager.
• Assure compliance of general and trial-specific clinical research safety related processes with SOPs, FDA, NIH, and global regulations for the reporting of adverse events to regulatory agencies.
• Perform clinical review of serious adverse event forms and associated documentation.
• Communicate effectively with sites and trial personnel to obtain high quality safety data in a timely fashion.
• Create draft clinical narrative for Medical Monitor review.
• Enter safety data into appropriate database in accordance to trial specific working instructions.
• Review data entry by Clinical Trials Assistants or Clinical Trials Specialists.
• Work closely with sponsor and trial personnel on relevant safety data issues. Obtain Medical Monitor review of trial-specific safety data.
• Create trial-specific data listings and reports for review by Safety Surveillance Associate III and/or Management.
• Provide trial-specific reports to trial personnel per trial-specific processes.
• Assist in the development of appropriate regulatory reports and associated documentation in accordance with SOPs and trial-specific processes under the direction of Safety Surveillance Associate III or Manager.
• Assist in the development and implementation of trial-specific safety data reconciliation processes.
• Provide routine updates and reporting to Safety Surveillance personnel and management to ensure timely communication regarding status of safety data and important safety related issues.
• Assist in the development routine evaluation and modification of Safety Surveillance general safety reporting processes and forms under direction of Management.
• Assist with other regulatory related duties.
• Participate in training Safety Surveillance personnel and other clinical research personnel on safety reporting regulations, processes, and procedures.

Work Environment

This position is 100% remote. Candidates must reside in states 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, PA.

Job Type & Location

This is a Contract position based out of Philadelphia, PA.

Pay and Benefits

The pay range for this position is $29.34 - $47.33/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 Type

This is a fully remote position.

Application Deadline

This position is anticipated to close on Jun 30, 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.