PV팀 정규직 채용(글로벌다국적제약사)

7년전부터 ADC항암제사업부 증설 --선도적인 표적항암제 개발 및 판매 마케팅 진행 /고혈압,고지혈증 전문의약품 아시아1~2위 다국적 제약사 /세계 15~16위 제약사 / 10년내 세계 10위권 진입가능/대기업 수준의 처우 대기업 수준의 처우임 ] 기본급+추가 경영성과급 전직원140%지급(급여대비)+개인성과급 연봉대비 11.2%이상 ~20%지급+년 2회 명절 상여지급+ 그외 년간복지비(160만원) ,자기개발비,식대 교통비,건강검진비등도 따로 지급함. 리프레시 휴가제 /유연근무제/육아휴직등 시행/ 잡플레닛3.8 처우업무환경 최우수사 담당업무] [1] Pharmacovigilance Area § To carry out PV activities in a proper and timely manner in accordance with the relevant regulations, SOPs and Code of Practice. § To report and manage Individual Case Safety Reports (ICSRs) for investigational and marketed products to the headquarter, partners and the regulatory authority within the required timelines. - Receive and triage of ICSRs; - Track and file ICSRs; - Communicate for ICSRs; - Conduct ICSRs reporting; - Follow-up on additional information; - Handle ICSRs-related inquiries; § To collect adverse events of investigational & marketed products and safety issues from various sources (e.g. literature, MIS query, media, HCP, patient, clinical study and etc.). § To report and manage safety issues for investigational & marketed products to the headquarter, partners and the regulatory authority within the required timelines. § To communicate with the regulatory authority and the headquarter for safety issues properly. § To monitor regulatory changes related to PV in a timely manner and take appropriate actions to cope with the changes by analyzing their impact on the business. § To cooperate with RA for handling product complaints and safety related issues regarding labeling changes. § To collaborate with relevant parties for global and local clinical trials (e.g. safety related document review, SAE reconciliation and SAE flow plan). § To prepare and maintain of PV agreement with co-promotional companies and to ensure their compliance with PV. § To prepare and execute the Risk Management Plan (RMP) properly. § To conduct and/or support active surveillance (e.g. PMS) as part of the RMP. § To prepare and submit aggregated reports (e.g. PSUR/PBRER, DSUR) in a timely manner. § To prepare safety data for product renewal. § To conduct or support PV training for all employees in a timely and efficient manner. § To support or manage the product liability issues. § To develop and maintain relevant SOPs for PV activities in accordance with global/Asia regional SOPs and regulations. § To manage PV system and data. § To collaborate with the headquarter and relevant functions like MR, MKT, MIS and IT for PV activities. § To perform other miscellaneous administrative tasks 문의및 접수]반석써치 김동훈상무이사 dookim@banseog.co.kr / 02-2177-9853/010-5235-8553 Requirements지원 자격] Requirement: At least 5 years of experience in drug safety or clinical trial management, Major in pharmacy, Korea Pharmacist *5년 이상 PV 또는 임상 등 관련 경력 *한국 약사 또는 간호사 면허 소지자 COMPETENCIES: Good understanding of regulation regarding safety reporting Good ability in working according to global standards Good written and spoken English capabilities Good knowledge of computer software Good interpersonal skills and communication skills Good collaboration skills Good presentation skills Good conflict management skills Good change management skills Good time management skills Problem-solving skills Ability to give prioritize tasks Active and open-minded person to handle multi tasks in the department Professional and positive attitude Have strong agility for the self-motivation/development to be a member of high-performing team