Safety Scientist

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Title:

Safety Scientist

Job ID:

64228

Location:

Wilmington, DE 

Classification:

Healthcare & Community

Salary:

$42.00

Salary Type:

per hour

Posted By:

Meera Vasant
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Job Type:

Full time

Posted:

08/09/2017

Start Date:

-

Telephone:

9177162626
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Job Description:

Hello,
 
I'm currently working on 

Safety Scientist, 

Wilmington, DE. Please let me know if you are interested to apply. 

Duration : 12-36 months

 

 

Under US Patient Safety Surveillance Team Leader’s supervision, to be accountable and responsible for handling the Food and Drug Administration (FDA) investigational new drug (IND) clinical trial Periodic Aggregate IND safety summary Reports (PAIR) for AstraZeneca Products Under Multiple INDs within Hematology and Oncology Therapeutic Area.

 

Accountabilities:

• Identify qualified oncology products with multiple INDs based on multiple sources

• Review the monthly schedule to ensure that all products are included in the list and communicate with PAIR Report Scheduler

• Notify the Regulatory Project Manager of all upcoming PAIR reports

• Work with relevant US PS stakeholders to gather relevant report data and tables

• Author all PAIR reports and complete all PAIR reports within the specified timeframes

• Work with Regulatory and Publishing for completion of the PAIR submission to FDA

• Monitor compliance of PAIR reports

 

Required:

• Bachelor’s degree in science/healthcare related field plus proven Patient Safety surveillance experience equivalence, and an excellent clinical background.

• At least 3 years patient safety experience and/or at least 3 years clinical or pharmaceutical experience

• Demonstrated working knowledge of FDA and ICH regulations relevant to Patient Safety and adverse event reporting

• Knowledge and firm understanding of FDA expedited reporting requirements for Clinical Trial SUSAR reports

• Knowledge and firm understanding of the FDA Final Rule Requirements

• Strong project management skills

• Strong communication skills

• Previous experience with authoring Periodic Reports

 

Desired:

• Advanced degree in science/healthcare-related field

• Ability to synthesize and analyze complex medical and scientific data

• Working knowledge of epidemiology

• Demonstrated capabilities in: Project management, Time management, Presentation skills, Strong attention to detail and organization

• Demonstrated ability to perform with minimal supervision

• Works as a team player and supports the development of other team members

Company Info
The Veritas Healthcare Solutions LLC 469 7th Ave
New York, NY, United States

Web Site: http://www.theveritashealthcare.com/

Company Profile