PV – CR(Clinical research) Associate/¿Ü±¹°èÁ¦¾àȸ»ç
¿Ü±¹°è Á¦¾àȸ»ç¿¡¼ PV – CR(Clinical research) Associate ¸¦ ã°í °è½Ê´Ï´Ù.
ÁÖ¿ä ¾÷¹«´Â ¾Æ·¡¿Í °°½À´Ï´Ù.
Main Accountability
- Manage collection, processing, documentation, reporting and follow-up
of all adverse event (AE) reports and adverse drug reactions (ADR) for company¡¯s products
from clinical trials, post-marketing studies (PMS), Spontaneous Reports (SR), registries,
commercial programs, etc.
- Ensure recording and tracking of receipts/submissions/distributions of Individual
Case Safety Reports (ICSR), Serious Adverse Events (SAEs), Investigator Notifications (IN),
Periodic Safety Report Updates (PSUR) and Annual Safety Reports (ASR) and ensure
reporting/submission/distribution of safety re-ports/updates/information
(e.g. ICSR, SAE, IN, PSUR ASR, changes in risk benefit) to local Health Au-thorities (HA)
according to regulatory requirements.
- Management and maintenance all local relevant PV databases.
- Ensure appropriate agreements are in place for local licensor or licensee to comply
with all require-ment for reporting ADRs/AEs.
- Participate in local/regional clinical operations activities and local business meetings as required.
- Interact with CRO s and develop alliance with preferable CROs for ensuring qualified
clinical operation.
- Supervise overall project performance in a team and ensure qualities through co-visit
and co-monitoring.
- Responsible for implementing of assigned clinical trials as a project owner.
- Manage and support CRA s in all clinical operation activities and issues.
Requirements :
1. PV°æ·Â 2³â ÀÌ»óÀÇ ºÐ
2. PV + CR °æ·Â °¡Áö°í °è½Å ºÐ ¼±È£ÇÕ´Ï´Ù.
3. ¾àÇÐÀü°øÀÚ
4. ¿µ¾î °¡´ÉÇϽŠºÐ
´ã´çÀÚ : (ÁÖ)¸¶ÀϽºÅæ¼Ä¡ (www.mstone.co.kr) ¿øÇö¼÷»ó¹«
¿¬¶ôó : 02-2050-0299, 010-8911-5018
À̸ÞÀÏ : hs@mstone.co.kr
Áö¿ø½Ã Á¦Ãâ¼·ù : ±¹¿µ¹®À̷¼
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