Patient Safety Solutions Associate

The Patient Safety Solutions Associate will assist with clinical safety operations related to products, including managing the entire adverse events process. This role involves processing expeditable adverse events, ensuring timely submission to clients and regulatory agencies. The position requires adherence to legal requirements and the provision of quality service in a cost-effective manner.

Responsibilities

• Assist in processing Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs).
• Maintain adverse event tracking systems.
• Set up and maintain project files and central documentation.
• Report ESRs and PSRs to clients, Regulatory Authorities, Ethics Committees, and investigators as required.
• Log incoming Adverse Event (AE)/Serious Adverse Event (SAE) reports into the tracking application.
• Process adverse events, including data entry and narrative writing.
• Perform listedness assessments against appropriate labels for marketed products.
• Generate queries for missing or discrepant information in consultation with medical staff.
• Submit expedited SAE reports within agreed timelines.
• Conduct peer/quality reviews of processed reports and support trend analysis.
• Reconcile databases and maintain adverse event reporting files as applicable.
• Work within the Quality Management System framework, adhering to SOPs and WIs.
• Prepare safety study files for archiving upon project completion.
• Arrange and schedule meetings or teleconferences.
• Train and mentor PSS Assistants or peers.
• Build and maintain positive PSS relationships across functional units.
• Ensure compliance with regulatory requirements and study-specific plans.
• Assume responsibility for the quality of processed data.
• Provide administrative support to PSS personnel.
• Perform other duties as needed or assigned.

• Experience in Drug Safety, Medical Affairs, Clinical Data Entry, Clinical Data Management, Regulatory Affairs, and Quality Assurance.
• 1-2 years of Safety experience or relevant experience is preferred.
• Proficiency in English and local language for speaking, writing, and reading.

• Associate degree or 6 months to 1 year of Safety experience.
• BS/BA with 0-6 months to 1 year of Safety experience.
• MS/MA with 0-6 months of Safety experience.
• PharmD with 0-6 months of Safety experience. A one-year residency or fellowship is considered relevant experience.
• Preferred disciplines: Biological Sciences, Pharmacy, Nursing, Medical Sciences, Life Sciences, or related areas.
• Relevant and equivalent experience may be considered in lieu of educational requirements.

The position is based in an office in Durham, NC, and requires 20 hours per week (80 hours a month). Onsite presence is necessary for mail handling tasks, including signing and mailing documents.

Job Type & Location

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

The pay range for this position is $35.00 - $36.00/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)

This is a fully onsite position in Durham,NC.

This position is anticipated to close on May 3, 2026.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

Actalent is an equal opportunity employer.

About Actalent

Actalent is a global leader in engineering and sciences services. For more than 40 years, we’ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000 extraordinary employees who connect their passion with purpose every day.

Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.

Salary : $35 - $36