Clinical Safety Manager
- Employer
- RemeGen Biosciences, Inc.
- Location
- 20850, Rockville
- Start date
- Jun 29, 2022
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- Discipline
- Clinical, Drug Safety/Pharmacovigilance
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- BioCapital
•Assist in the establishment of the company's pharmacovigilance system to ensure the implementation of pharmacovigilance;
• Establish and timely update the company's PV-related processes and SOPs and other controlled documents in accordance with regulatory and regulatory requirements to ensure process optimization;
• Evaluate and report ICSRs from the clinical trial phase and post-marketing products, and ensure that the ICSR is reported to the relevant regulatory authorities within the specified timeline as required by the regulations;
• Analyze and evaluate product safety data, perform signal detection, and develop effective risk control measures;
• Preparation and submission of safety-related documents (e.g.DSUR, PSUR, RMP, etc.);
• Review of pharmacovigilance related documents (such as protocol, investigator's brochure,SAE reconciliation plan, etc.);
• Assist in the preparation of pharmacovigilance related documents required for IND/BLA to support product application and post-marketing re-registration;
• Responsible for the annual report of pharmacovigilance;
• Provide pharmacovigilance training for relevant personnel within and outside the company;
• Assist the QPPV to cooperate with the audit and verification by regulatory authorities;
• Assist the QPPV to manage the pharmacovigilance team and ensure the orderly progress of various work;
• Focusing on the key objectives of project management, ensure the effective implementation of project safety work through cross-departmental cooperation and effective communication between internal and external customers.
• Review the project safety management plan and other relevant documents, such as the review of the safety part of the protocol.
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