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Reference Number:
NBSL-NJ
Job Description:
For our Fortune 50 Clients:-
Looking for a Medical Doctor with Safety Experience in Pharmaceutical Industry.
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**********Please send your resume in MS Word format at rajiv@mysunrisesys.com OR Do call me at 866-802-6485**********
Position: Safety Brand Manager/Brand Safety Leader 4 SPOTS.
1. Responsible for safety issue management from formation of International Project Team (IPT) through Life Cycle Management (post-approval)
2. Develops and is responsible for key internal safety documents from the formation of the IPT through Life Cycle Management. Reviews these documents regularly and updates as required (e.g. when significant new information received). Ensures that these, and all other project-related safety documents, are consistent with one another.
3. 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 . To this end, constitutes and runs the Safety Management Team. Ensures that this team appropriately reviews all safety data from various
sources (e.g. pre-clinical, clinical trial data presented by Clinical Trial Head (CTH) or Medical
Scientific Expert (MSE), post-marketing, literature) throughout the development process
4. Provides expert safety input to the clinical development program for assigned projects/brands
5. Provides expert medical input to trial and project level Drug Safety Monitoring Board activities for assigned projects/products, as required, whilst remaining blinded
6. Responsible for initial development and updates of safety information in Basic Prescribing Information
(core global labeling), including addressing safety issues optimally in all project/ product labeling claims
7. Responsible for responses to inquiries 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 Country Pharma Organization (CPO) requests involving safety issues. Provides integrated safety input into all regulatory documents required during active development. Ensures safety information communicated to EU Qualified Person in a timely fashion.
8. Facilitates involvement of external experts (e.g. authors of white papers, members of trialspecific data safety monitoring boards , ad-hoc support for HA meetings, etc.)
9. Prepares and may present brand safety issues to internal Novartis Boards and other meetings.
10. Provides relevant input for IPT, ICT and TA Expert Panel meetings, as needed
11. Collaborates productively with colleagues from Clinical Research, Drug Regulatory Affairs, Medical Affairs, Medical Information, Statistics, Safety Data Management, Epidemiology and other related departments.
12. Provides support as needed for licensing activities, regulatory authority inspections and for project/product recall activities
13. Serves as and performs activities of Pharmacovigilance Leader as needed
Skills:
3 years clinical experience postdoctoral
At least 5 years are in drug development in a major pharmaceutical company (of which 2 years in a global position), including 2 years in safety at an operational or medical position
Experience in preparing or contributing to preparation of clinical safety assessments and regulatory reports/submissions involving safety information
Experience in leading cross-functional, multi-cultural teams.
Experience with (safety or others) issue management.
Experience in drug development, clinical trial methodo logy, regulatory requirements, scientific methodology, statistics and writing of publications.
Education:
Medical Degree required. Specialty Board certification desirable.
Useful additional degrees:
Post graduate degree in Pharmaceutical Medicine; Master of Public Health in Epidemiology (or equivalent)
**********Please send your resume in MS Word format at rajiv@mysunrisesys.com OR Do call me at 866-802-6485**********
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Sincerely,
Rajiv Mishra
Sunrise Systems
rajiv@mysunrisesys.com
www.sunrisesys.com
866-802-6485
732-603-2208 (Fax)
****Please see my other Job Postings listed on www.dice.com.****
Experience Level:
5+ Years
Requirements:
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