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)