product safety lead.

job summary:
Responsible for all tasks related to the collection, processing, follow up and regulatory reporting of adverse events (AEs), serious AEs from Clinical Trials (SAEs), adverse events of interest (AEIs) and pregnancy reports for all client products marketed and investigational products. This position will routinely process all types of reports for all categories of products (medical device, cosmetic and OTC products).

 
location: Raleigh, North Carolina
job type: Contract
salary: $44 - 45 per hour
work hours: 8 to 4
education: Bachelors
 
responsibilities:
1 Post Marketing Adverse Event Processing

2 Clinical Study SAE Processing

3 On Time Submission of AE Reports

4 Evaluation of Individual AE Reports and Safety Data

5 Literature Reviews

6 Safety database proficiency

7 Review and Update of Departmental documents

8 Provides training regarding AE reporting

9 Audit Support and Support of Safety/Vigilance

 
qualifications:
Minimum Qualifications

- Bachelor's degree in a science or heath care-related field or RN/PharmD

- 5+ years of experience in drug safety or medical device vigilance (preferred) in an industry setting or equivalent

Preferred Qualifications

- Direct health care experience with injectable products highly desired

- Knowledge and experience with document management systems (EDMS, eTMF, etc.).

- Experience in vendor management.

- Demonstrates relationship building and problem-solving skills.

#LI-JW1

 
skills: Adverse Event (AE) Reporting

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).

This posting is open for thirty (30) days.