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.
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.
After a journey of growth spanning 27 years as Cadila Healthcare Ltd. and the Zydus Group, we have evolved and transformed ourselves in response to the changing times.
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.
Preparation of Clinical Study Reports CSR for EMEA, WHO, SAHPRA. TGA, US- FDA, Costa Rica, others regulatory and Appendices and formats as per projects