외국계 제약회사에서 다음과 같이 ‘PV&MI' 담당을 찾습니다.
* Job Title: PV&MI
* Position: 사원 - 과장급
1. Implement and maintain a pharmacovigilance and a medical information system for the products authorized in Korea territory
2. Ensure compliance with applicable regulatory requirements.
3. Ensure communication of national pharmacovigilance requirements to the Corporate Pharmacovigilance Team.
4. Process drug safety information from solicited and unsolicited sources in order to enable data entry into the corporate database by the Corporate Pharmacovigilance Team.
5. Report adverse events to the appropriate Korean Regulatory Authorities in accordance with local regulations.
6. Collaborate in the management of Post Marketing Surveillance programs, take responsibility in accordance with local regulations and communicate with the CR team proactively.
7. Maintain a log for all safety information and medical inquiries respectively.
8. Record and achieve related document for all safety information and medical inquiries.
9. Perform and document screening of local literature and local regulation updates periodically and communicate Corporate and internal stakeholders as necessary
10. Provide pharmacovigilance and medical information training to internal staff, and external partners, as required.
11. Maintain understanding of SOPs, Work Instructions, guidelines, and the drug development process.
12. Establish and maintain local Safety Data Exchange Agreements(SDEA)
13. Participate and lead pharmacovigilance audits and inspection, ensuring timely identification and implementation of respective CAPAs.
14. Review of promotional materials generated in company to ensure quality and compliance of related regulations in collaboration with internal stakeholders.
15. Answer and review the answers of medical inquiries from both internal and external customers related to all the company products.
1. An advanced degree is required (Pharmacist)-한국 약사 자격 필수
2. A Fluent in English, both speaking and writing
3. Prior experience in Pharmacovigilance
4. 3 or more years of biotech/pharmaceutical and/or clinical experience is preferred (PV&MI 근무자 선호, 혹은 유간부서 경험자 선호)
5. Excellent ability in searching and interpreting medical literature.
6. Highlymotivated with high personal and ethical standards
Those who are interested in this opportunity, please submit your Resume (CV) in MS Word Format by email urgently. Only qualified candidates will be contacted for interview. All resumes not contacted will be kept in DB confidentially for future positions.
KIM, Kyung Jin (Ian Kim)
CEO / Exdigm Inc.