외국계 제약회사에서 다음과 같이 “약물감시 (PV: PharmacoVigilancea)” 인재를 찾습니다.
* Job Title  :  약물감시 (PV: Pharmacovigilance)
* Position :  대리 - 사원급
* Gender            :  Male or Female
* Location :  서울

[RESPONSIBILITIES]
- Case Handling and Periodic reports – receive, log, follow up, report and archive and report adverse events and periodic reports in accordance with global, regional Standard Operating Procedures (SOPs) and Local Authority’s Regulation, as well as submitting the Serious Adverse Events from clinical studies to the Local Authorities according to the local regulations
- Compliance – ensure all cases are reported to Global PV within timelines and events requiring submission to local authorities reported within regulatory timelines. Monitor and report compliance and submit monthly report to the regional Pharmacovigilance function. Keep abreast with the local regulatory developments in Pharmacovigilance.
- Reconciliation – ensure safety information contained in any other database / spreadsheet within the local company is consistent with the PV case register via a reconciliation process
- Contracts – review Safety Data Exchange Agreements, co-distribution, co-marketing, in-licensing and contracts to ensure PV roles and responsibilities are defined.
- Training – imparting basic AE reporting training to field personnel in the country operations and ensuring maintenance of training records in accordance with applicable global, regional and country Standard Operating Procedures (SOPs)

[QUALIFICATIONS]
- Pharmacist preferred
- Aggressive and open mind character & PC Proficiency
- Good relationship with co-workers and relevant 3rd parties
- Excellent analytical & problem solving skills
- Excellent oral & written communication & interpersonal skills
- Operates effectively in a team environment
- Ability to work under strict deadlines and changing priorities with some supervision
- Working knowledge of related safety regulations and ICH-GCP
- Exposure to relationships with regulatory authorities
- Proficient in English

Those who are interested in this opportunity, please submit your English 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: 02-557-8272
Mobile: 010-8722-1272
Email: ceo@exdigm.com