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 within the
📌 Medical Reviewer (India)
🏢 Sitero
📍 India
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