Job Title: Medical Reviewer
Location: Remote
Job Summary: We manage and review individual case safety reports (ICSRs) to support ongoing global pharmacovigilance activities and ensure compliance with safety regulations. Our team plays a vital role in maintaining drug safety through medical assessment, regulatory reporting, and collaborative communication with internal and external partners.
Responsibilities:
- Review all applicable ICSRs and communicate with global and internal teams, including external partners, as necessary.
- Perform medical review for all types of ICSRs from multiple sources, including clinical trials and post-marketing data.
- Conduct causality, seriousness, and labeling assessments based on current regulatory guidelines and product safety information.
- Identify potential safety signals from ICSRs, escalate issues appropriately, and raise follow-up queries to obtain additional information for medical assessment.
Required:
- At least 3-4 years of experience in pharmacovigilance, including primary clinical case work and medical review of ICSRs; oncology experience required.
- Comprehensive knowledge of pharmacovigilance regulations, aggregate safety reporting, risk management, and signal management in various jurisdictions.
- Proficiency with MedDRA coding and Argus safety databases, as well as familiarity with Windows applications and the ability to learn new programs.
- Medical degree (MD or MBBS), or internationally recognized equivalent, from an accredited medical school required.
About SSI People: With over 26 years of industry experience, SSi People has built its reputation and expertise on putting people first. Everything we do works toward delivering exceptional experience for our consultants, our clients, and our internal team. Through a genuine commitment to people in everything we do. We have developed refined processes and a stellar internal team to deliver talent quickly. More importantly, we focus on building long-term relationships, not transactions. Putting people first is just what we do well.
By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from SSi People and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy here: SSi People Privacy Policy