Drug Safety Associate

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

• 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.

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