Description
Medison stands as a distinctive global pharmaceutical company, driven by an unwavering purpose: to deliver groundbreaking therapies to patients suffering from rare and severe diseases across international markets. We believe that all patients, wherever they are in the world, have the right to get access to the best available novel treatments, and we are here to make this happen. As we continue our global expansion, we seek individuals who share our passion and principles, are eager to build and make a difference.
We are patient-centric, innovative, agile, and always ahead.
Come and join our growing team!
Responsibilities
Pharmacovigilance specialist for Medison Korea, will be responsible for assisting the RA and PV Manager on the management of mainly PV activities and associated workflow and appropriate maintenance. To build and ensure appropriate organisational capabilities and deliverables.
Pharmacovigilance:
- Deputy of RA&PV manager in South Korea
- responsible for the pharmacovigilance knowledge and expertise in the territory
- supports the local pharmacovigilance activity regarding Company’s products
- ensures compliance with the local and global PV requirements and as agreed with the partners in the territory
- Act as the subject area expert in PV for South Korea
- Develop internal capabilities in the areas of PV to maintain full compliance both from a local regulatory perspective and in alignment with Global Medison requirements.
- Establishing and maintaining local pharmacovigilance system and procedures covering all activities required by regulations and safety agreements with partners.
- Create and revise local PV SOPs
- Collect and manage safety information obtained through various sources;
- Manage the submission of safety data to the local Regulatory Authority according to local regulations.
- Support the partners in local PV activities by providing information and governance of local PV activities
- Oversight/active involvement in localisation and implementation of RMP and additional Risk Minimization Measures in collaboration with other departments, partners, vendors.
- Create/conduct PV training programs to local Medison employees (including new employees) and vendors and ensure maintenance of awareness of drug safety reporting in general.
- Create and manage SDEAs/PVAs with partners and vendors. Ensure implementation of the relevant activities in the territory;
- Oversight and managing PV vendor
- Responsible for prepare PSUR and RMP implementation report
- Ensure PV inspection readiness at all times
- Develop PMS (or any local phase IV studies) procedure and support study operation from PV perspective, to collect safety information
- Assist RA & PV Manager in local PV budgeting.
- Assist with additional tasks as assigned by RA & PV Manager.
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General:
- Demonstrate effective communication, collaboration and leadership with all necessary stakeholders and partners to maximize ability to execute objectives in timely manner and with efficiency.
- Represent the organization with internal & external stakeholders.
Requirements
- A minimum of 3~7+ years of experience in PV activities
- Pharmacist license(KR) is highly preferred
- Experience in managing RMP and PMS activities is preferred.
- Experience in reporting local ICSR cases to MFDS is preferred.
- Experience in managing vendors, working with international companies
- Working knowledge of the MFDS, international GxP regulations, guidelines, and emerging regulatory progresses.
- Knowledge of PV system design, development, implementation, and maintenance
- Experience with PV audits (internal and external)
- Not afraid to challenge the Status Quo and provide suggestions for improvement
- Highly collaborative team player that can successfully provide valuable feedback
- Ability to cope with ambiguity and lean structure
- Ability to work in highly dynamic and fast-growing organisation with demonstrated capability to be at ease in a matrix structure with ability to influence
