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WHAT
IN
Director Drug Safety
Job
ImClone Systems Incorporated
US
-
Bridgewater ,
New Jersey
Job Code - 430536
Position - Full-Time
Job First Active on: Sunday, November 01, 2009
APPLY TO THIS JOB (You will be applying directly to ImClone Systems Incorporated for this position!)
JOB DESCRIPTION: Director, Drug Safety
GENERAL SUMMARY:
Assist in the overall management of Drug Safety operations, including preparation and review of safety reports, case assessment, assessment for safety signals, preparation of standard as well as ad hoc adverse event reports, staff management and mentoring, database maintenance and upgrades, and contribution to regulatory and clinical regulatory documents.
ESSENTIAL DUTIES AND
RESPONSIBILITIES:
1.Assist head of drug safety in overall functional management
2.Responsible for the day-to-day drug safety operations to ensure adequate staff coverage, process integrity and overall compliance.
3.Manage and serve as resource for teams of safety professionals, with mentorship and professional development responsibilities
4.Manage multiple pharmacovigilance related projects simultaneously
5.Conduct employee performance evaluations, reviews, and disciplinary action when necessary
6.Develop and monitor personnel, compliance and work related metrics
7.Manage CRO and Vendor contracts and relationships
8.Participate in Project Core teams and Sub-teams
9.Plan, develop and manage departmental staff training, and participate/ contribute (as relevant) to the training of other departmental personnel (e.g. Clinical, Medical, Regulatory, CRO and Investigator personnel)
10.Serve as Inter-departmental and cross-functional liaison
11.Prepare safety monitoring procedures and other required safety documentation for clinical trials
12.Contribute to the improvement of electronic safety database and archiving system
13.Serve as monitor for and maintain integrity of internal processes (SOPs, Forms, Work Instructions, Workflow, etc), CQI and compliance
14.Oversee aggregate reporting and distribution processes
15.Coordinate and oversee review of documents for safety input
16.Communicate safety issues to project teams and other stakeholders within the company
17.Demonstrate a thorough understanding of applicable safety regulatory standards in the countries where clinical studies are being conducted
18.Demonstrate a thorough understanding and experience with safety database function and electronic transmission of safety reports to regulatory authorities and development partners
19.Establish a good working relationship with associated groups, especially clinical trials, project management, medical writing, regulatory affairs, legal, development partners, CROs, vendors, etc.
20.Demonstrate a working knowledge of individual and aggregate adverse event report assessment, reporting, and regulatory categorization; and safety database operation and management
ESSENTIAL KNOWLEDGE,
SKILLS, EXPERIENCE:
1.Minimum of bachelor’s degree in a recognized health profession (e.g. nursing, pharmacy, etc.) with a strong clinical practice background. Oncology therapeutics experience strongly preferred. Post-graduate education and management experience preferred.
2.Minimum of 10 years of progressive work experience in the pharmaceutical industry, particularly in Drug Safety/ Pharmacovigilance
3.Prior management/supervisory experience
4.Outstanding oral and written communication skills
5.Familiarity with industry principles of drug/ biotechnology product development, pharmacology, biostatistics, regulatory function, clinical trial methodology, pharmacoepidemiology, and regulations
6.Proficiency working with electronic safety databases (e.g. ARISg), other relevant computer applications and spreadsheets
REQUIREMENTS - QUALIFICATIONS: Director, Drug Safety
See information above
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