Emcure Pharmaceuticals Limited Hiring for Medical reviewer for Ahmedabad R&D center, minimum Qualification required for this role MBBS/MD with 1 to 3 years of experience of PV/clinical.
Interested please share cv @ manojt.kumar@emcure.co.in
Activities/Job Responsibilities:
- Medical review and approval of selected literature articles.
- Medical review of individual case safety reports in safety database and perform labeling and causality assessment as per company’s procedural documents.
- Also, perform follow up with the reporter when needed to get the additional or missing information.
- Medical review of aggregate reports including periodic safety update reports, periodic adverse drug experience reports, etc and provide a medical and scientific conclusion to the benefit and risk analysis of the product.
- Provide medical conclusion for signal management activity for the company’s product and keep oversight on risk minimization activities.
- Providing inputs into the timely response to safety-related queries and product queries as needed received from different regulatory agencies, healthcare professionals and consumers for domestic and internationally marketed products.
- Provide medical inputs to the prepared Product labels (e.g. Summary of product characteristics- SmPCs) and Patient information leaflets for domestic and internationally marketed products for US, EU & Emerging countries as per the current required regulatory guidelines.
- Provide response to pharmacovigilance related queries from various departments (formulation, regulatory, marketing)
- Provide inputs to clinical and non-clinical overviews/documents if required for domestic and international regulatory submission for US, EU & Emerging countries as per the current required regulatory guidelines.
- Provide medical backup support to global pharmacovigilance head as well as pharmacovigilance responsible person or pharmacovigilance officer in charge.
- Escalate to line manager any significant safety-related issue if identified with the company’s product.
- To guide and train pharmacovigilance employees to use more effective methodologies and improve efficiency. Conducting pharmacovigilance training as needed to applicable personnel of the company.
- Contributing to the ongoing enhancement of Pharmacovigilance processes and preparing and reviewing standard operating procedures related to pharmacovigilance, as needed.
- Providing support as needed for regulatory authority inspections and audits.
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