Pharmaceutical Clinical Associates, LLC
-
Bridgewater,
NJ
Drug Safety Specialist
Clinical
New Jersey
Bridgewater
1st Shift
GENERAL SUMMARY:
Provide assistance in the management of all adverse event reports received by ImClone, including but not limited to clinical and regulatory assessment of individual reports, preparation of reports, maintenance of electronic database, report follow-up and preparation of standard as well as ad hoc adverse event reports.
ESSENTIAL DUTIES AND
RESPONSIBILITIES:
1. Assess individual adverse event report for seriousness, labeling status and relatedness
2. Prepare adverse event report in the electronic safety database for review
3. Assist in the maintenance of report integrity in the electronic database
4. Maintain filing system integrity for report hardcopy
5. Follow-up adverse event reports according to SOP
6. Prepare standard and ad hoc safety reports as required
7. Assist in the maintenance of adverse event dictionary
8. Contribute to the improvement of electronic safety database and filing system
9. Establish a good working relationship with associated groups, especially clinical trials, project management, medical writing, regulatory affairs, and development/ marketing partners
10. Apply sound clinical judgment to case assessment
ESSENTIAL KNOWLEDGE,
SKILLS, EXPERIENCE:
1. Healthcare professional, preferably a registered nurse or pharmacist
2. Minimum 2 years of pharmaceutical industry experience in drug safety and/or clinical trials
3. Basic understanding of FDA’s CFR and ICH guidelines as they pertain to adverse event reporting
4. Knowledge of and ability to work with computers and spreadsheets
5. College degree in nursing, pharmacy, health sciences or related fields with at least 3 years of relevant experience
Experience and Skills:
Type or Copy/Paste Requirements here
Additional Information:
Job Level: Any
Number of Openings: 1
Years of Experience:
Level of Education: Any
Salary: TBD
Starting Date : TBD
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Pharmaceutical Clinical Associates is always accepting employment inquiries from professionals interested in our opportunites. If you are interested in career opportunities at Pharmaceutical Clinical Associates please use our online resume formto apply. Pharmaceutical Clinical Associates is an Equal Opportunity Employer.
Bridgewater, NJ
Bridgewater, New Jersey
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