* 담당업무
상세조건 |
● 업무개요
○ Implement, and Monitor GPV SOPs/WPs/Ols, Local SOPs/Ols, and local regulatory requirements for reporting
safety related information in ensuring compliance with Bayer global/local procedures, national and international
regulations/standards/guidelines, AND participate in the process of developing and review of local SOPs/Ols.
○ Collection, documentation, and follow-up of(serious)adverse events, safety information and
safety issues in timely manner
○ Perform data entry into the safety database (Argus-LAM) according to stipulated timelines. To ensure to be in line
with Global requirement and standard. To do other related work to keep the pharmacovigilance system running well
○ Submit(S)AEs reports from clinical studies, safety information and spontaneous reports related to Bayer products
according to local regulations to health authorities and take/support the relevant actions on the safety issues in close
cooperation with RA, the relevant teams, and PVCH
○ In case of safety issues or crises, ensure a close cooperation with the local relevant teams and
global organization for safety issue management based on guidance of PVCH
○ Work with the relevant Business Unit(s)within the area of responsibility to provide PV support as required, and
Conduct other adhoc PV activities according to company SOPs and local and international regulations
○ Responsible for PV training to relevant stakeholders
○ Be well-acquainted with BHC-RD-OI-001(Responsibilities and Tasks of PV Country Heads)
●응시자격
○ Education
※ Bachelor degree or above, major in pharmacy, nursing or medical science
○ Skills
※ Professional knowledge on pharmacy, nursing or medical science
※ Knowledge on the regulations/guidelines related to Pharmacovigilance
※ Excellent interpersonal and communication skills with business partners and team members
※ High caliber candidate with good command of the English language
※ Good computer skill(MS-office, internet/intranet)
○ Experiences
※ Pharmacovigilance, Medical Information and Clinical Research-related experience preferred
● 접수기간 및 접수방법
○ 접수기간
- 2014년 04월 28일 (월) ~ 2014년 05월 12일 (월) 까지
○ 접수방법
- 당사 홈페이지 접수 이용
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