Sitero is an emerging leader in Clinical services and software solutions for the life sciences industry. We have experience and expertise in a diverse range of therapeutic areas and focus on innovative, technology-enabled solutions that allow our clients to focus on their core strengths. For early phase studies through Phase III clinical trials, our experienced team delivers high-touch services and technology to ensure the safety of all stakeholders across the clinical research community with an emphasis on ethics, compliance, and innovation.
Job Title: Medical Reviewer
Location: Mysore/Hybrid
Function: Drug Safety
DESCRIPTION:
Medical Reviewer is the key contact person for assigned clinical development or marketed products, responsible for safety strategy and major safety deliverables, including both early and late-stage development, as assigned. He/she is accountable for safety and risk management activities for one or more assigned products. He/she will manage cross-functional assessment of benefit-risk profile and communication of safety information for assigned product(s).
The individual will be an integral part of a group of safety professionals within Sitero and will closely collaborate with safety teams in Contract Research Organizations (CROs) and partners. He/she will need to maintain medical knowledge as required by the role, solid and current knowledge of drug safety and pharmacovigilance regulations, pharmacovigilance practices, safety surveillance and risk-management practices.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
· Analyzes, reviews, and interprets safety data, both non-clinical and clinical.
· Performs medical review of ICSRs, and other drug safety information from multiple sources, including clinical trials, spontaneous and solicited reports, aggregate and literature reports.
· Provides technical and medical expertise in medical assessment of causality of Individual Case Safety Report (ICSR) as necessary, including the assessment of quality withi
📌 Medical Reviewer (Mysuru)
🏢 Sitero
📍 Mysuru
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