Amgen PMS Manager in Seoul, South Korea
PURPOSE OF THE ROLE:
Primary responsible person in Korea ensuring the implementation and conduct of post marketing surveillance studies from study planning to close-out in accordance with Amgen SOPs and local PMS regulation
Oversee PMS at a local level according to local regulations and MFDS requirements.
Collaborate with cross functional stakeholders to ensure timely execution of PMS deliverables
Taking delegation of Safety Management Officer responsibilities with regards to Post Marketing Surveillance and re-examination.
Ensuring implementation and conduct of study in accordance with Amgen SOPs and local PMS regulation by providing appropriate advice/consultation to Clinical Study Team (CST) as below,
Providing input on PMS study design and protocol development needs ensuring they consider local regulatory requirements
Planning, management and reporting of PMS periodic/re-examination within timelines
Overseeing PMS systems, processes and activities continuously
Providing guidance for country level documents to supplement core regulatory package for local HA submission and responses to regulatory questions
Providing guidance for Ethics/IRB documents and translation to country representative to support submission and responses to Ethics questions
Providing guidance and input to study report which is submitted to regulatory agency according to local regulation
Providing training to all relevant staff about PMS processes
Identifying any risk/issue related to PMS, escalating it to the CST and Korea General Manager to solve the risk/issue in a timely manner
Providing the guidance on per patient and site budget according to local regulations
Leading communication for PMS with MFDS (preferred to be used as one of responsibilities, not one of key activities)
Supporting the CST to drive effective decision making by providing advice on PMS regulations and MFDS requirements.
Support the management of vendors (CRO) to the required standards in both in-house and outsourced model
Providing local insights/expertise regarding decision on sites to proceed to SEV and escalation of issues identified during SEV in collaboration with local field medical team and GSO-SM.
Consulting on country level timelines, sites and patient enrolment estimates for GSO-SM team with the discussion with local regulatory affairs
Be a member of RST, LST, CST meetings as a representative local study team
- Master’s degree & 3 years of directly related experience or equivalent
- Bachelor’s degree & 5 years of directly related experience or equivalent
7 years work experience in life sciences or medically related field, including 4 years of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company
Experience in oversight of external vendors (e.g. CROs, central labs, imaging vendors, etc.)
Advanced knowledge of global clinical trial management
Clinical trial processes and operations
Extensive knowledge of Korean PMS regulations and guidelines
Project and Program management including oversight of study deliverable, budgets and timelines
Time, cost and quality metrics, Key performance indicators
Relevant therapeutic knowledge
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
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