Safety Writer

Job DescriptionEssential Functions:- Author and review Aggregate reports (PSURs/PBRERs, PADERs/Annual Reports, ACO, DSUR) for submission to local and other health authorities.- Author and review Risk Management Plans (RMPs) as part of regular pharmacovigilance activities.- Author and Quality Review of Signal Management Reports.- Perform literature searches...

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,...

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...

Job DescriptionMajor accountabilities:- To author and review high quality clinical and safety documents: non-registration Clinical Study Reports (CSR), Development Safety Update Reports (DSUR), Risk Management Plans (RMP).- 2. Lead for outsourced Narrative projects. Coordinate other outsourced activities in RWS.- 3. Core member of Clinical Trial Team (CTT) /...

Job SummaryWe are seeking an experienced Specification Writer to join our team.As a Specification Writer, you will be responsible for ensuring that specifications are accurate and meet the required standards.You will work closely with regional teams to review and update specifications in line with regular renewal dates.About the RoleThe role of a...

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 not...

Summary To write and or edit under guidance high quality clinical and safety documents non registration Clinical Study Reports CSR Development Safety Update Reports DSUR Clinical Trial Registration Documents or Patient NarrativesScientific Writer IILocation Hyderabad LI HybridAbout the Role To write and or edit under guidance high quality clinical...

900! That is the approximate number of individual regulatory documents the dynamic team at Regulatory Writing and Submissions (RWS) planned, developed and wrote. And that’s just in 2019! Come, join a global team of nearly 200 regulatory professionals - life scientists, clinicians and project managers across 6 countries and support Novartis in its mission...

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the...

Regulatory WriterThis is a high-profile position that requires a skilled Regulatory Writer to create and review clinical and safety documents.Author high-quality clinical and safety documents, including non-registration Clinical Study Reports (CSR), Development Safety Update Reports (DSUR), and Risk Management Plans (RMP).Lead outsourced Narrative projects...