유명 바이오 제약회사에서 다음과 같이 'PV (Pharmacovigilance) Associate'를 찾고 있습니다.
* Position: PV (Pharmacovigilance) Associate
* Department: Medical Team
* Location: Songdo

[RESPONSIBILITIES]
- Case processing of solicited & unsolicited adverse event case reports (case data entry, case review and assessment, MedDRA coding, drafting initial narratives) 
- Monitor incoming cases and queries in PV mailbox
- Regulatory submission of individual case safety report (ICSR)
- Safety monitoring for clinical trials
- Aggregate reports preparation 
- Review medical literature and perform literature screening for drug safety
- Establish PV-related SOP’s and monitor PV regulations & Management of external service provider for delegated PV 
- Archiv safety documents

[QUALIFICATIONS]
- Bachelor’s degree or above (Major: Pharmacy, Nursing preferred)
- At least 1 year of experience in a pharmaceutical/biotechnology company (as a PV or clinical research associate)
- Possess up-to-date knowledge of PV regulations and guidelines (GVP/ICH)
- Good verbal and written communication skills in English 
- High level of integrity with working ethics

Those who are interested in this opportunity, please submit your Resume 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

Kyung Jin KIM
CEO & Executive Search Consultant
Exdigm Inc
Phone: 070-8260-3646
Mobile: 010-8722-1272
Email: ceo@exdigm.com