Drug Safety Associate
Parexel International Corporation
United States of America, Remote
Parexel is looking for a Drug Safety Associate with drug safety case processing experience to join our team in North America!
The Drug Safety Associate will provide technical and process-related support to drug safety management (clinical trial and post-marketed), ensuring compliance with relevant regulations and Standard Operating Procedures (SOPs).
Key Accountabilities:Global Pharmacovigilance Processing Group (GPPG):
Assist in development of project-specific safety procedures, workflows, and templates.
Assist in project-specific safety database setup, development of data entry guidelines, and user acceptance testing
Triage incoming reports for completeness, legibility, and validity
Electronic documentation and quality control of drug safety information
Data entry of case reports into safety database / tracking system
Request follow-up and perform query management
Coding of data in the safety database
Writing case narratives
Create and maintain project-specific working files, case report files and project central files
Assist with additional Drug Safety Specialist and/or Safety Service Project Leader (SSPL) activities, as required
Inform Line Manager (LM)/Team Manager, Safety Services Project Leader (SSPL) or Project Leader (PL) and Regional Head of PV Operations of potential change-in-scope of projects
Participate in client and investigator meetings, as required
Attend internal, drug safety and project-specific training sessions
Perform literature searches
Preparation for, participation in, and follow-up on audits and inspections
Delegate work as appropriate to Drug Safety Assistants
Skills:
Analytical and problem-solving skills
Able to perform database/literature searches.
Excellent interpersonal skills, verbal / written communication skills
Excellent organizational and prioritization skills
Ability to work collaboratively and effectively in a team environment.
Client focused approach to work
Experience with computer applications
Knowledge and Experience:
Related experience gained in a drug development and/or healthcare environment is an advantage.
Ideal candidate will have at least 2- 3 years of recent Argus case processing experience, along with 1-2 years of clinical trial case processing experience desired.
AT LEAST 3+ year of recent Post-Marketing experience preferred.
Education:
Degree in Pharmacy, Nursing, Life Science, or other health-related field, or equivalent qualification/work experience
Associates/diploma degree in any of the above with appropriate work experience
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
Job posted: 2023-08-21
