1.0 - 5.0 years

0 Lacs

pune, maharashtra

On-site

As a Medical Safety Expert, your primary responsibility will be to provide medical safety expertise to Sponsors of drugs, devices, and combination products during the post marketing period. This will involve undertaking the primary medical review of cases, including assessing seriousness, listed/labeling, causality, adverse event coding, and narrative review. You will be required to update and document case data daily, provide training and guidance to the case processing team on medical aspects, and ensure all assigned deliverables meet quality, compliance, and productivity standards. Additionally, you will perform secondary medical reviews and retrospective reviews to measure the quality of deliverables, identify error trends, and contribute to process improvement activities. Your role may also involve aggregate medical review and signal detection/analysis activities. It is essential to maintain client relationships, promote a culture of high customer service, and participate in enhancing processes across the company. To qualify for this position, you must hold a Bachelor's degree in medical science, MD, DO, or equivalent. Relevant experience may be considered in lieu of educational requirements. Proficiency in English at ILR level 3+ for speaking and level 4+ for writing/reading is required. You should have a working knowledge of medical sciences, diagnosis, therapeutics, drug treatments, regulatory requirements for Clinical Research, and ICH-GCP guidelines. Preferred qualifications include a good understanding of regulatory requirements related to Pharmacovigilance and up to 2 years of experience in the pharmaceutical industry, particularly in pharmacovigilance or clinical research. Clinical practice experience of 1 to 2 years is also preferred. This role may involve working in an office or home-based environment as requested by the line manager. Your dedication to ensuring high-quality deliverables, maintaining strong client relationships, and contributing to process improvements will be key to your success in this role.,

Posted 3 days ago

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