Write brief narratives summarizing the ICSR criteria and other potentially safety-relevant information in each article. Demonstrates understanding of client’s drugs labels and uses that knowledge effectively when performing the safety assessments.
Pfizer is the world's premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support.
ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology,
Thorough knowledge of EU, MENA and ASEAN markets country requirements, regulatory affairs procedures for initial submission, licensing, post-approval submission management
Having exposure related Environment Monitoring in formulation, water analysis, various Microbiological test like sterility, BET, MLT etc. Having exposure related to regulatory plant and basic know of GLP GMP. Ready to work in rotational shift.
Production QMS Quality Management System Handling of QMS activities like Deviation, Incident, Investigation, CCP, Protocol Preparation, Risk Assessment etc.
Responsible for Execution of Placebo, Scale up & Trial batches. Review Validation protocol, Report, responsible for validation batches manufacturing. Preparation of scale up and trial batch summary to support the commercialization of products.
A Masters M.Pharm or M.Sc. or M.Tech. or M.E. or Bachelors B.Tech or B.E. or B.Pharm. An understanding of the Process Development and Industrial perspective of Biotherapeutics/ Biosimilars. Basic understanding of analytical techniques, statistical analysis, data management and analysis.