- 이미지뷰 -
[Sanofi/사노피] Post Marketing Surveillance lead
Post Marketing Surveillance lead
국/영문 이력서 및 자기소개서를 하나로 통합하여 MS Word 또는 PDF로 첨부 해주십시오
이메일 firstname.lastname@example.org (지원은 위의 링크에서만 가능)
합격자에 한하여 개별 통보 드립니다.
The Post Marketing Surveillance lead (PMSL) is assigned to fulfil country pharmacovigilance obligations relating to medicinal products and biologics for which Sanofi holds the Marketing Authorisation. The PMS Lead is primarily responsible for the conduct of post-approval PMS commitments according to country regulations.
- In collaboration with Medical affairs and Contract Research Organisation (CRO), participate in the development of PMS strategy and ensure that all active Surveillance, local Phase IV and comparative observational studies comply with local regulations and are aligned with global processes and governance.
- Oversee and coordinate all aspects of active Surveillance, local Phase IV and comparative observational studies utilizing the appropriate local and global functions to deliver the required data for re-examination and RMP by the Korean regulatory authority.
- Act as an interface with MFDS regarding PMS in collaboration with CSH (Country Safety Head).
- Establish and manage communication with local/global stakeholders for PMS operations.
- Coordinate the development and maintenance (including revision and archiving as necessary) of PMS plans and related documents based on PMS strategy agreed by all relevant stakeholders.
- Local support and interface of CROs and vendors, in alignment with global clinical development and operations procedures and governance directives.
- Ensure appropriate contracts with the study site are in writing and preserved according to the Korean regulatory authority regulations.
- Coordinate data gathering for the preparation of PMS/RMP periodic report and re-examination report.
- Review, implement and maintain all PMS SOPs, as applicable, to enable PMS to be implemented accurately and smoothly and to align with company’s policies, standards and procedures.
- Implement PMS training for all relevant internal stakeholders in alignment with systems and processes used globally.
- Support investigator / study site communication as necessary.
- Coach Jr. CPL to conduct PMS operation.
Ability to present clear messages accurately in both written and spoken English from complex information/data to all
levels in the organization.
University degree in Health Sciences or equivalent
Experience & knowledge
5+ years’ experience work in Clinical Operations. PMS work experience is preferred.
- Knowledge of Korean regulatory authority requirements, KGCP/ICH-GCP.
- Knowledge of Korean PV and Risk Management regulatory requirements
- Management, leadership and communication skills, organizational, analytical and planning abilities, reactivity to emergent needs, able to prioritize, time management.
- Influencing skills in a matrix organization, through a collaborative style with the establishment of credibility and strong working relationships with cross-functional teams.
지원자 자유이력서 양식
[137-040] 서울 서초구 반포동 반포대로 235
최종수정일 : 2020년 04월 22일
본 정보는 (주) 사노피-아벤티스코리아에서 제공한 자료이며, 파마메디잡는(은) 기재된 내용에 대한 오류와 지연, 사용자가 이를 신뢰하여 취한 조치에 대하여 책임을 지지 않습니다. 본 정보는 파마메디잡의 동의 없이 재배포할 수 없습니다.
선택하신 이력서와 입력하신 내용이 해당업체의 담당자에게 이메일로 전송됩니다.
제휴 및 광고문의
설립일 : 2015년 12월 02일 l 개인정보책임자 : 윤병호
사업자등록번호 : 372-23-00108
| 통신판매업신고 : 제 2015-시흥-0669호
Co. Ltd. All rights reserved.