Senior Specialist, Drug Safety
3 일전에
Job Description
The Position
The Senior Pharmacovigilance Specialist (Sr PV Specialist) reports to the PV Associate Director and is responsible for the daily case management activities for assigned country(ies).
The PV Senior Specialist is responsible for all PV activities including aggregate and individual case safety report (ICSR) health authority submissions, compliance monitoring, and may serve as the PV contact with local stakeholders, headquarters (HQ) and the local health authority. The PV Senior Specialist collaborates with colleagues to ensure compliance with local laws and regulations, including backing up colleagues and adjusting schedules such that there is no gap in adverse event reporting and safety oversight.
The Sr. Specialist is also responsible for PV activities (as delegated/assigned by their Manager) which may include but are not limited to: PV intake, management and negotiation of local PV agreements, local due diligence activities, participation in audits and inspections and related readiness activities, review of local initiatives for compliance with PV requirements, SOP management, local training, communication of safety issues, people development, and/or special projects and can work on these delegated activities with minimal supervision.
The Sr. Specialist may serve as the deputy/back-up Qualified Person for PV (QPPV) / Local PV Contact / Local Responsible PV person as required per local PV legislation. If he/she is nominated to HA as L-QPPV, any commercial activities, which has impact on L-QPPV activities, are not allowed. In the absence of their Manager he/she is responsible for managing all day-to-day activities of the PV department and serves as back-up.
Required Education, Experience and Skills
- The incumbent must have a health, life science, or medical science degree or equivalent by education / experience and be fluent in English (written and spoken) while proficient in local language.
- He/she should have a minimum of 7 years of industry experience in pharmacovigilance.
- Advanced Collaboration and Partnering
- Strong communication skill, strategic thinking and project management
- Good business operations and knowledge of field
- Deep knowledge of PV regulations and regulatory trends
Secondary Job Description
Must Haves:
- 국내약사면허소지자
- 총 7년 이상 및 최소 5년 이상 PV 경력
Good to Haves:
- 프로젝트 리드 경험
- 전반적인 PV 업무 경험
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