Review and assess local country labels to identify deviations from the core labeling and propose topics for further cross-functional assessment during the periodic core labeling review process
Responsible for the drug surveillance program including the necessary follow-up, risk assessment, and relatedness to product on adverse reaction reports, oversight of safety in clinical trials and post marketing programs.
Hands-on experience in Bag Filling Machine, preferably SHINVA Bag Filling / PLUMAT. Handling complex manufacturing processes such as Emulsion and Suspension.
Operate and monitor granulation, blending and compression machines. Ensure optimal machine performance and adherence to batch manufacturing records. Cronus Pharma
As a Patient Safety Associate II/Specialist, you will support global pharmacovigilance activities that advance new treatments for patients. This position plays a key role in safety case processing, regulatory submissions, literature surveillance, and compliance with international regulations.
Review of complaints related to ExM which are received for various suppliers. Review the adequacy of investigations and coordinate with internal and external stake holders for closure.