Drug Safety Specialist
Company: Selva Infosys LLC
- Location: Manchester, United States
- Seniority: Entry level
- Employment type: Full-time
- Posted: 8 days ago
- Offer language: English
Job description
Company Description Selva Infosys LLC operates at the intersection of medical practice compliance and automated workflow optimization for healthcare organizations. The company provides a complete financial lifecycle framework that helps reduce operational friction and speed up turnaround times. Its solutions are designed to ensure healthcare systems capture the full value of patient care while maintaining high standards of regulatory compliance. Team members contribute to improving healthcare efficiency and accuracy through technology-driven processes and robust support services.
Role Description The Drug Safety Specialist is a full-time, on-site role based in Manchester, NJ. This role is responsible for monitoring, assessing, and documenting the safety profile of medications used within supported healthcare systems. Day-to-day tasks include reviewing adverse event reports, analyzing safety data from clinical and post-marketing settings, and ensuring compliance with internal policies and external regulatory requirements. The specialist collaborates with medical, pharmacy, and regulatory teams to address safety concerns, support risk management strategies, and maintain accurate safety documentation. The role also involves preparing safety summaries, supporting audits and inspections, and contributing to continuous improvement of drug safety processes.
Qualifications
- Strong understanding of regulatory requirements and experience in regulatory affairs relevant to drug safety.
- Background in pharmacy or medicine with practical exposure to medication safety and therapeutic use.
- Familiarity with clinical trials, including safety monitoring, adverse event reporting, and data documentation.
- Ability to interpret medical and pharmacological information and apply it to risk assessment and safety decisions.
- Bachelor’s or advanced degree in Pharmacy, Nursing, Medicine, Life Sciences, or a related field.
- Excellent analytical, documentation, and communication skills, with attention to detail and accuracy.
- Experience working with healthcare compliance, pharmacovigilance systems, or safety databases is preferred.
- Ability to work collaboratively with cross-functional clinical, regulatory, and operations teams on-site.
