Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company’s integrity & quality standards
Pharmacovigilance (PV) Associate will be responsible for all assigned Clinical Safety and post-marketing PV activities. The PV Associate will be part of the newly developed, lean and efficient, Global Safety Data Management team
Strong negotiation skills to facilitate, guide, influence, and produce a unified approach within a global, cross-functional environment. Ability to handle multiple tasks in a timely and professional manner under demanding conditions.
Acme Group began its journey in 2005 with a bold mission of becoming a leader in the contract manufacturing space and a preferred business partner for pharmaceutical companies seeking world-class capabilities and scalable operations.
Perform and monitor in-process Quality Assurance activities during the manufacturing process. Responsible to perform line clearance activities in different stages of drug substances manufacturing and Monitoring of cleanroom behavior, aseptic activities, BMR review. Preferred for biological experience.
Prepare, compile and review regulatory submissions for ROW markets. Prepare CTD/ACTD dossiers for non-regulated markets. Ensure timely dossier submissions and respond to regulatory queries.