Safety Specialist II Navitas Life Sciences

2.0 - 6.0 years

0 Lacs

karnataka

On-site

As a Safety Specialist II at our company, your role will involve the following responsibilities: - Authoring and reviewing various Aggregate Safety Reports such as DSURs, PBRERs, PSURs, PADERs, and Canadian Aggregate Reports as required by the project. - Reviewing aggregate safety data, generating line listings (LL) and summary tabulations (ST), and incorporating them into the appropriate templates. - Analyzing safety and regulatory data provided by clients to prepare comprehensive Aggregate Reports. - Conducting literature screening to include significant safety articles in the respective sections of aggregate reports. - Compiling benefit-risk evaluation sections provided by medical reviewe...

Posted 1 week ago

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Senior/Lead Medical Reviewer Navitas Life Sciences

1.0 - 5.0 years

0 Lacs

karnataka

On-site

As a Senior/Lead Medical Reviewer with 1 3+ years of experience in Aggregate Reporting, Signal Management, or RMP, you will play a crucial role in our team. Your responsibilities will include overseeing the implementation of operational tasks in safety writing, monitoring service performance, and mentoring employees to ensure independent work within timelines, budget, and quality standards. Your duties will involve reviewing RMP/PSUR or any aggregate documents for medical cohesiveness, managing the logistical aspects of safety reports" development, and collaborating with authors from different line functions to meet client and Health Authorities" requirements. You will also be responsible fo...

Posted 1 month ago

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