Patient Safety Specialist I

Job Title: Patient Safety Specialist IJob Description The Patient Safety Specialist I is responsible for the receipt, processing, triage, and quality assessment of all inbound safety information, including adverse events and technical complaints, for U.S. marketed and investigational drug and device products. This role ensures that all safety records are collected, documented, and maintained in full compliance with internal procedures and external regulatory requirements. The position involves extensive interaction with patients, caregivers, healthcare professionals, and internal stakeholders, and requires strong pharmacovigilance expertise, exceptional attention to detail, and a commitment to high-quality customer service. Responsibilities + Receive, process, triage, and perform quality assessment of all inbound safety information, including adverse events and technical complaints, for marketed and investigational products. + Enter and maintain accurate and complete case information in local intake, complaint, and global safety databases. + Conduct duplicate searches to ensure accurate case consolidation and prevent double-reporting. + Perform product coding and MedDRA coding for all reported adverse events and technical complaints. + Generate clear, concise, and medically accurate case narratives based on source documentation. + Assess reported events against current approved product labeling to determine expectedness and labeling status. + Receive inbound and make outbound calls related to adverse events and technical complaints, including handling requests for refunds or product replacements in accordance with procedures. + Perform timely and accurate data entry and review of adverse events and associated technical complaints, ensuring high-quality case documentation. + Provide ongoing feedback and guidance to other case handlers to support their development and maintain excellent case quality. + Handle incoming and outgoing follow-up correspondence to obtain additional information necessary for case completion. + Collect and document detailed information obtained during outbound follow-up calls with patients, caregivers, and healthcare professionals. + Perform triage, case classification, and assignment of cases to appropriate team members based on established criteria. + Handle escalated calls related to adverse events and technical complaints with professionalism and appropriate urgency. + Assist with training and mentoring new hires, sharing best practices and supporting their onboarding into case handling processes. + Perform reconciliations between internal and external data sources to ensure completeness and accuracy of safety data. + Assist with coordination and distribution of workload across the team to meet timelines and performance expectations. + Conduct call monitoring to support quality assurance and identify opportunities for improvement in call handling. + Support the identification of trends and patterns in safety data and technical complaints, and contribute to the implementation of corrective actions. + Coordinate configuration requests for safety and complaint databases in collaboration with relevant stakeholders. + Serve as a subject matter expert for case handling activities during audits and inspections, providing documentation and explanations as needed. + Build customer loyalty by delivering high-quality, empathetic, and professional customer service. + Provide accurate and timely responses to product information questions and other inquiries using approved product labeling and call scripts. + Identify procedural deficiencies and opportunities for process improvement, make recommendations to management, and support implementation of agreed solutions. + Contribute to department-related projects as assigned, ensuring deliverables meet quality and compliance standards. + Maintain strict confidentiality and handle sensitive information in accordance with company policies and regulatory requirements. + Collaborate effectively with internal partners in Patient Safety, Medical Information, Field Sales, Customer Complaints Center, suppliers, and patient-centric support teams. + Engage professionally with external stakeholders, including patients, caregivers, and healthcare professionals, to obtain and clarify safety information. Essential Skills + Bacheloru2019s degree required, preferably in a medical or science-related discipline; relevant experience may substitute for the degree where appropriate (for example, a Registered Nurse with clinical experience). + Minimum of 2 years of progressively responsible and relevant pharmacovigilance experience, including MedDRA coding and adverse event identification. + Hands-on case processing experience in pharmacovigilance, including end-to-end management of individual case safety reports. + Exceptional knowledge of medical terminology and pharmacovigilance terminology. + Experience with Argus drug safety database. + Strong analytical thinking skills, with the ability to interpret clinical information and identify key safety details. + Proficiency with Windows, Microsoft Word, Excel, and Outlook. + Strong oral and written communication skills, with the ability to communicate clearly with internal and external stakeholders. + Demonstrated ability to work with sensitive or confidential information with discretion and professionalism. + Strong attention to detail, ensuring accuracy and completeness in case documentation and data entry. + Ability to manage multiple priorities and demands in a fast-paced environment while meeting timelines. + Strong planning, organizational, and time management skills. + Ability to interact effectively with various levels of the organization and form strong working relationships with stakeholders. Additional Skills & Qualifications + A minimum of 2 years of customer service experience is preferred, ideally in a healthcare, call center, or patient-facing environment. + Knowledge of disease states supported by the organization, such as diabetes, obesity, hemophilia, and growth hormone disorders, is preferred. + Experience participating in or supporting audits and inspections is preferred. + Experience working in a call center environment and with drug safety databases beyond Argus is preferred. + Experience with Veeva systems is preferred. + Familiarity with complaint handling processes and technical product complaints is beneficial. + Ability to identify process improvement opportunities and contribute to the development and implementation of solutions. + Demonstrated ability to mentor and support new team members is an advantage. + Bi-lingual Spanishu2013English language skills are a plus. Work Environment This role is based onsite in Plainsboro with a standard schedule of Monday through Friday, 8:30 a.m. to 5:00 p.m., for up to 40 hours per week. After an initial period and in alignment with business needs and manager approval, there may be flexibility to work from home a few days per week. The work environment is fast-paced and highly regulated, focused on patient safety, regulatory compliance, and high-quality customer service. The position involves frequent use of drug safety and complaint databases, including Argus and potentially Veeva, as well as standard office software such as Microsoft Word, Excel, Outlook, and Windows-based applications. Daily work includes phone and electronic communication with patients, caregivers, healthcare professionals, and internal teams. The culture emphasizes collaboration across Patient Safety, Medical Information, Field Sales, customer support, and other internal stakeholders, with a strong focus on accuracy, confidentiality, and continuous improvement in processes and patient experience. Professional office attire is typically expected in the onsite setting. Job Type & Location This is a Contract position based out of Princeton, NJ. Pay and Benefits The pay range for this position is $28.35 - $28.35/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: u2022 Medical, dental & vision u2022 Critical Illness, Accident, and Hospital u2022 401(k) Retirement Plan u2013 Pre-tax and Roth post-tax contributions available u2022 Life Insurance (Voluntary Life & AD&D for the employee and dependents) u2022 Short and long-term disability u2022 Health Spending Account (HSA) u2022 Transportation benefits u2022 Employee Assistance Program u2022 Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a hybrid position in Princeton,NJ. Application Deadline This position is anticipated to close on Apr 21, 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, weu2019ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APACu2014with 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 .

Created: 2026-04-16