본문
Position: PV manager
Main responsibilities of this role are:
- Monitor all PV activities including Compassionate Use, clinical trials, performed by Shaperon; and escalate safety-related issues in a timely manner to ensure appropriate mitigation
- Set up and maintain a quality PV management system, PV reports, and business contingency plan.
- Manage Individual Case Safety Reports (ICSRs) from all relevant sources and detect new safety signals on Shaperon products.
- Ensure reporting compliance with ICSR and aggregate report responsibility to MFDS and related regulatory agencies.
- Communicate with Health Authority, investigators in clinical trials and other stakeholders for safety information.
- Provide PV training to all employees and business vendors.
- Respond to PV inspection and audits conducted by MFDS and any other agencies.
Minimum Requirement
- Over 5 years of experience in safety related position from pharmaceutical field. Clinical Trial experience preferred.
- Pharmacist license is an essential prerequisite 약사면허소지자
- Experience in PV quality system set up
- Knowledge of local and global PV regulations
- Experience in safety data use.
- Fluent English (preferred)
|