3 Product Monographs Jobs

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5.0 - 9.0 years

0 Lacs

maharashtra

On-site

As the Senior Manager of Patient Safety at ADVANZ PHARMA, your primary responsibility will be to monitor and manage all aspects of updating Reference Safety Documents for all ADVANZ PHARMA products globally. You will need to maintain these documents in accordance with applicable guidelines, ensuring a global process along with region-specific processes for writing and managing reference safety documents like CCDS and SmPC. Your experience in writing reference safety documents for various types of drugs will be crucial for this role. **Key Responsibilities:** - Act as a subject matter expert in global labeling requirements, driving continuous improvement initiatives, and upholding high-qualit...

Posted 5 days ago

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2.0 - 7.0 years

10 - 15 Lacs

mumbai suburban, mumbai (all areas)

Work from Office

Our Client a reputed Pharma company - Post : Deputy Medical Manager Services & PVOI Gender : Female Location : Lower Parel, Mumbai Experience : Min 2 years in Medico Marketing within the Pharmaceutical Industry Qualification : M. Pharm (Pharmacolgy) / D. Pharma Job Profile Provide scientific support to brands by delivering the latest scientific information on products, therapy areas, and clinical guidelines Develop and ensure the quality of scientific materials, including Product Monographs, LBLs, VAs, PSIs, PIs, and PLIs Conduct medical training sessions and product training for field personnel Contribute to new product ideation, including indication expansion, unique dosage forms, and nove...

Posted 1 month ago

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2.0 - 8.0 years

0 Lacs

kochi, kerala

On-site

You will be working at Silmed Scientific, an organization dedicated to public health safety through scientific evaluation and assessment of healthcare products. The company aims to ensure the global availability of safe products and fosters a unique working culture. As a Regulatory Medical Writer at Silmed Scientific, your primary responsibilities will include: - Authoring and reviewing Regulatory submission documents for pharmaceutical marketing authorization in Europe and the United States. - Developing Common Technical Document (CTD) modules like nonclinical and clinical overviews & summaries (Module 2.4, 2.5, 2.6, and 2.7), expert reports, safety & efficacy summaries, as well as Aggregat...

Posted 2 months ago

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