Medical Safety Expert

**Summary**: Provide support for medical safety management within the Patient Safety & Pharmacovigilance department, including medical review and assessments of Individual Case Safety Reports (ICSR), aggregate reports, co - authoring safety documents, assisting in providing safety input to regulatory and clinical documents, as well as ad-hoc Health Authority...

Summary -Responsible for the drug surveillance program including the necessary follow-up risk assessment and relatedness to product on adverse reaction reports oversight of safety in clinical trials and post marketing programs Participates in the resolution of any legal liability and complying with governmental regulations Provides and contributes...

Summary In close collaboration with the Global Program Safety Lead GPSL provides robust safety evaluation expertise and medical innovation in order to improve patients lives and impact on overall Novartis results As a member of the Medical Safety organization prioritizes the safety of patients ensures optimal patient safety for assigned compounds and shares...

**Major accountabilities**: - Provide support according to the needs for delivery activities, co-authoring safety documents and assisting in providing safety input to regulatory and clinical documents, as well as ad hoc Health Authority queries. - Assist the GPSL/MSL/MSE in monitoring the safety profile of products including with activities such as...

Summary In close collaboration with the Global Program Safety Lead GPSL provides robust safety evaluation expertise and medical innovation in order to improve patients lives and impact on overall Novartis results Ensures optimal patient safety for assigned compounds by identifying new safety signals early using internal and external spontaneous reporting...

Company Description Dr Reddy s Laboratories Ltd is a leading multinational pharmaceutical company based across global locations Each of our 24 000 plus employees comes to work every day for one collective purpose to accelerate access to affordable and innovative medicines because Good Health Can t Wait We started in 1984 with a modest investment 20...

Job DescriptionJob summary We are seeking a seasoned individual to provide crucial medical oversight for clinical trials, ensuring ICH GCP (International Conference on Harmonization Good Clinical Practices) and protocol compliance, prioritizing subject safety, and contributing to the success of biopharmaceutical advancements. The ideal candidate will play a...

392687BR **Expert Regulatory Writer**: India **About the role** Position Title: Expert Regulatory Writer About the role: Expert Regulatory Writer Location - Hyderabad #LI Hybrid The number of regulatory documents we authored last year. As an Expert Regulatory Writer you will develop documents which cover all Novartis therapeutic areas and therapies,...

**Description** **Safety Physician** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the...

2600+ Aggregate Reports annually! Dynamic teams at Novartis are committed to scientifically evaluate benefit-risk profile of the marketed products and collaborate with Health Authorities towards the ultimate goal of Patient Safety. Your skills & experience will help us on our journey of re-imagining patient safety. - Your responsibilities include, but are...