What are the responsibilities and job description for the Drug Safety Associate position at Parexel - USA?
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):
Skills:
Knowledge and Experience:
Education:
.
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
- Excellent 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
- MUST HAVE - at least 2 years of Argus case processing experience
- Prior CAR T experience would be a plus
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
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