Documentation and Document Control: Manage the complete lifecycle (preparation, issuance, retrieval, and destruction) of all QA documents, including SOPs, Logbooks, BMRs, and BPRs, while maintaining the documentation cell.
Good knowledge of ANDA submission activities and post-approval procedures and related ICH and USFDA guidelines. Exposure of the Sterile dosage form / complex injectable dosage form and brief manufacturing process and key regulatory aspects. Amneal Pharmaceuticals. Qualification : B.Pharm, M.Pharm
The Senior Pharmacovigilance Safety Scientist, Benefit Risk is expected to be professional and diligent and liaise with the director and management group members within the team on any issues, as well as coordinate the work with the senior PV Scientists. Pharma, Life Science candidates to Join ProPharma
Provide submission and contribute to the technical related regulatory strategy, intelligence and knowledge required to develop, register, and maintain global products. Sandoz
Interfaces with various internal and external parties to implement projects, prepares Confidentiality Disclosure Agreements, Letters of Intent and Member Agreements based on contractual considerations; reviewing all contractual documents for accuracy and coordinating internal and external approvals. Thermo Fisher Scientific
Pharmacovigilance Operations Manager at Amgen oversees the operations of the pharmacovigilance department, including the handling of adverse event reports, risk management, and safety communication. They ensure compliance with global safety regulations and guidelines. Amgen
Monitor and route incoming safety information to the appropriate project teams. Record all ICSR documentation and track cases in accordance with sponsor/customer specifications; distribute incoming mail and faxes.