Novartis Vacancies – Life Science Medical Safety Writer Job
Novartis Vacancies – Life Science Medical Safety Writer Job. Life Science candidates apply online for a Medical Safety Writer position that is available at Novartis. Novartis is hiring bsc/msc/phd candidates, as per the details below in their Research & Development area:
Job Title: Medical Safety Writer(Aggregate report writing- PSUR,PBRER)
Job ID: 292413BR
Location: Hyderabad, AP
Division: Global Drug Development
Business Unit: CMO & PATIENT SAFETY GDD
Employment Type: Full-time
Your responsibilities include, however, are not limited to:
- Lead preparation of global periodic safety reports for newly launched products. Lead coordination with GLFs to guarantee information received, analyzed and also incorporated into ARs based on the regulatory requirements.
- Independent QC of ARs to make sure the info presented in AR is complete, consistent and also compliant to regulatory as well as Novartis criteria
- Support in creating a strategy for data analyses as well as presentation in international periodic safety reports Support in addressing the Health Authority (HA) comments adequately in PSURs.
- Support in the development of safety document templates and Standard Operating Procedures pertaining to safety aggregate reports.
- Add to international projects focusing on process & quality improvement initiatives. Contribute as subject matter expert throughout Health Authorities inspections/audits and also add-in development, implementation of appropriate Corrective and also Preventative Actions (CAPA).
- Train and mentor brand-new CMO&PS associates as well as associates from various other line functions on medical safety writing & periodic reporting matters.
- Support Head, Safety Report Writing/Head, Aggregate reports as well as assist with the recruitment of brand-new staff.
- Graduate/Post Graduate/Doctorate degree in Life Sciences/Pharmacy/Medical Sciences or equivalent degree Fluency in English.
- Knowledge of various other languages preferable. 4 to 8 years’ experience in drug safety/ development or carefully related areas of duty, with a minimum of 3 years’ experience in safety/ medical/scientific/regulatory writing ideally, at the very least 2 years of experience in safety writing
- Sound expertise in data analysis as well as presentation Strong project management and also communication skills. Ability to lead international as well as cross-functional workgroups superb understanding of drug development
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