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Patient Safety Specialist
- Contract
- Pharmacology
- United States
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?
À±½·ÊÓÆµ 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 j.cerchio@proclinical.com
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.
À±½·ÊÓÆµ is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. À±½·ÊÓÆµ is acting as an Employment Agency in relation to this vacancy.
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