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: Drug Safety Associate (DSA) Location: Mysore Function: Drug Safety DESCRIPTION:
Drug Safety Associate is a safety professional responsible for assessing the safety of pharmaceutical drugs undergoing clinical trials or once they are in the market. Using standard guidelines, they determine whether the medication causes any adverse reactions in patients and report their findings back to regulatory bodies and health authorities.
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, robust 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, literature and any other relevant sources
• Responsible for performing end to end case processing of Individual case safety reports to meet regulatory timelines
• Perform initial evaluation of spontaneously reported adverse events including reports from post marketing surveillance studies
• Responsible for identifying duplicate/invalid ICSRs
• Perform case processing from clinical trial, literature, spontaneous, market research, social media and solicited cases fo
📌 Drug Safety Associate (India)
🏢 Sitero
📍 India