Patient Safety Specialist

Patient Safety Specialist - Contract - Plainsboro, NJ

Are you passionate about patient safety and experienced in managing adverse event reporting in a fast‑paced, collaborative environment?

Proclinical is seeking a Patient Safety Specialist to support the receipt, processing, and quality assessment of safety information, including adverse events and technical complaints, for marketed and investigational products.

Primary Responsibilities:

This role ensures compliance with internal and external safety reporting requirements and involves collaboration with various internal teams and external stakeholders.

Skills & Requirements:

• Background in medical or science-related disciplines preferred; relevant experience may substitute for formal education (e.g., Registered Nurse with clinical experience).
• Proficiency in pharmacovigilance processes, including MedDRA coding and adverse event identification.
• Strong knowledge of medical and pharmacovigilance terminology.
• Experience in customer service, call center operations, and drug safety databases is advantageous.
• Analytical thinking, attention to detail, and ability to manage multiple priorities in a fast-paced environment.
• Proficiency in Microsoft Office Suite (Word, Excel, Outlook).
• Strong communication skills and ability to handle sensitive or confidential information.
• Familiarity with disease states such as diabetes, obesity, hemophilia, and growth hormone disorders is a plus.
• Bilingual proficiency in Spanish and English is an added advantage.

The Patient Safety Specialist's responsibilities will be:

• Process adverse events and technical complaints, including duplicate searches, product coding, MedDRA coding, narrative generation, and labeling assessments.
• Manage inbound and outbound calls related to adverse events and technical complaints, including handling refund or replacement requests.
• Perform data entry, case classification, triage, and assignment while ensuring high-quality case documentation.
• Conduct follow-up correspondence and document information received during follow-up calls.
• Handle escalated calls and assist with workload coordination and distribution.
• Support training and mentoring of new hires and provide ongoing feedback to ensure case quality.
• Perform reconciliations, call monitoring, and assist with database configuration requests.
• Identify trends, recommend process improvements, and support implementation of corrective actions.
• Serve as a Subject Matter Expert during audits and inspections.
• Provide accurate and professional responses to product-related inquiries using approved resources.
• Participate in department-related projects and identify opportunities for procedural enhancements.

Compensation:

• $25 to $28 per hour.

If you are having difficulty in applying or if you have any questions, please contact Jackie Cerchio at [email protected]

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.

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