글로벌 제약회사
송파구(잠실역) 소재


재택근무: 수습 3개월 후 주 2회 가능
매월 둘째 주 금요일 Family day 실시(1시 퇴근)
법정연차 외 여름휴가 3일 추가 부여
휴대폰 경비: 월 최대 6만 5천원까지 지원
과일, 샌드위치 등 아침 제공

PV Associate
1년 파견계약직/연장가능 

약물감시 업무 경험자 

약사 우대 - 약사는 신입도 지원 가능

Roles & Responsibilities:
Timely report the safety information related to marketed products to Novo Nordisk Global Patient Safety and Health Authority

1.        Report safety information related to marketed products (including medical devices) to the Health Authority
2.        Monitor and conduct follow-up on reported safety information
3.        Receive reports of safety information from rPMS/Post-marketing NIS and report them to Global Patient Safety 
4.        and the Health Authority
5.        Monitor the PV mailbox for safety information
6.        Report foreign cases to the Health Authority
7.        Report Health Authority reporting compliance to Global Patient Safety
8.        Support reconciliation with service vendors, if needed

Ensure safety activities are documented and archive the related documents according to internal and external requirements

1.        Document all activities related to Pharmacovigilance when documentation is required
2.        Archive documents and records for the required retention period and ensure retrieval of archived documentation
3.        Maintain the archiving list

Support maintenance of the pharmacovigilance system 

1.        Provide training and support for audits/inspections related to Pharmacovigilance
2.        Manage product exchange requests and related processes
3.        Perform external requirement monitoring

Manage safety cases from clinical trials

1.        Report SUSARs from clinical trials to the Health Authority
2.        Distribute SUSARs to the Korea CDC

 Pharmacist license required      

 At least 1 year of relevant professional working experience preferred    

 Proficient in speaking and writing local language and English