|
|
| Reference # : |
10j107440 |
|
Title : |
NR-Clinical Research Physician III -624 |
| State : |
New Jersey |
|
Date : |
Aug 16, 2010 |
| Experience Level : |
|
|
|
|
| Position Type : |
Clinical Research Physician III |
|
|
|
|
| Description |
This position is for a leading pharmaceutical company . Below are the details of the engagement,. If you are available and interested please send me your updated word resume & your expected hourly rate on W2 ASAP.
Looking forward to hearing from you soon.
Work Location : Florham Park, NJ
Job Title: Clinical Research Physician III
Duration: 6+ months (extendable) contract on W2
Duties : 1. Responsible for safety issue management from end of Phase I (POC) through Life Cycle Man-agement.
2. Responsible for overall signal detection, monitoring, evaluation, interpretation and appropriate management of safety information, based on information from all relevant line functions, postmarketing data, and other sources.
3. Develops and updates, at milestones, the safety profiling and risk management plan from end of Phase I (POC) through Life Cycle Management, as relevant.
4. Leads Safety Management Team. Serves as safety representative on Global Program Teams (extended or core member)
5. Manages Drug Safety Monitoring Board activities for assigned projects/products, as required.
6. Responsible for responses to inquires from regulatory authorities or health care professionals on safety issues. Prepares safety data for health authority review boards. Responsible for responses to legal queries and CPO requests involving safety issues. Ensures safety informa-tion communicated to EU Qualified Person in a timely fashion.
7. Provides integrated safety input into all safety relevant parts of regulatory documents (ie IB, CDS, SCS, RMP, CO etc) required during active development, submission phase and during marketing phase.
8. Co-ordinates involvement of external experts (e.g. authors of “white papers”, members of trial-specific data safety monitoring boards, ad-hoc support for HA meetings, etc.)
9. Prepares and may present project/product safety issues to internal Novartis Boards, or expert panels and other meetings
10. Collaborates productively with colleagues from Clinical Research, Drug Regulatory Affairs, Medical Affairs, Medical Information, Statistics, Safety Data Management, Epidemiology and other related departments.
11. Provides support as needed for licensing activities, regulatory authority inspections and for project/product recall activities.
12. Serves as and performs activities of Pharmacovigilance Leader as needed.
Skills: 3 years medical experience postdoctoral
- At least 5 years in industry or health authority or CRO (of which 2 years in a global position), in-cluding a minimum of 3 years in drug safety
- Experience in preparing clinical safety assessments, risk/benefit evaluations and regulatory re-ports
- Experience in leading cross-functional, multi-cultural teams
- Experience in preparing RMPs, PSURs, Submission dossiers (SCS).
Education: MD
---
Sree Kanth
Resource Specialist
NewAge Clinical,
A Division of NewAgeSys, Inc.
231 Clarksville Road, Suite 200,
Princeton Junction,NJ 08550
Tel#: 609-945-2237, Fax: 609-228-4079
email: sree@newageclinical.com
|
|
|
| For IT jobs with NewAgeSys, please click on the following link:
|
| NewAgeSys
|
|
