PV (PharmacoVigilance 약물감시) Manager
- Company
- 외국계 제약회사
- Position
- PV (PharmacoVigilance 약물감시) Manager
- Status
- CLOSE
외국계 제약회사에서 다음과 같이 “약물감시 (PV: PharmacoVigilance) Manager” 를 찾습니다.
* Job Title: 약물감시 (PV: Pharmacovigilance)Manager
* Position: 차장 - 과장급
* Gender : Male or Female
* Location: 서울
[RESPONSIBILITIES]
- Provide high quality, balanced and timely information to requests for medical Information from both internal and external customers.
- Process adverse event information from clinical trials and spontaneous reports including Clinical data entry into the electronic database.
- Report adverse events to the appropriate Korea Regulatory Authorities
- Manage PMS and take responsibility and communicate CR team proactively
- Maintain a log, compliance information and filing system for all pharmacovigilance
Cases.
- Provide pharmacovigilance training to internal staff, and external partners, as required.
- Participates in the management of the Safety and Corporate Pharmacovigilance department with the following actions:
- Ensures the execution of the Safety Management Plan/Safety Reporting Plan.
- Initiate Risk management plan and collaborate Risk management plan
- Evaluates processes for potential improvement in efficiency and effectiveness and recommends changes.
- All other duties as assigned from time to time.
- Maintains understanding of SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, and the drug development process.
[QUALIFICATIONS]
- An advanced degree is required (Pharmacist)
- 8 or more years of biotech/pharmaceutical and/or clinical experience is preferred
- Ability to manage multiple assignments simultaneously, work independently and as part of a team.
- Prior experience in Pharmacovigilance
- Requires initiative
- Excellent ability in searching and interpreting medical literature.
- Good interpersonal and team skills with ability to build consensus
- Results-oriented work ethic
- Strategic problem solving skills
- Highly motivated with high personal and ethical standards
- Proficient in English
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.
Mobile: 010-8722-1272
Email: ceo@exdigm.com
