Drug Safety Associate

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POST DATE 8/25/2016
END DATE 10/17/2016

PAREXEL Billerica, MA

Billerica, MA
AJE Ref #
Job Classification
Full Time
Job Type
Company Ref #
Entry Level (0 - 2 years)
High School Diploma or GED


Join PAREXEL as a Drug Safety Associate and work alongside members of our highly experienced Pharmacovigilance Team in our Billerica, MA office!

The Drug Safety Associate will provide technical and process-related support to drug safety management (clinical trial and post-marketed) and medical monitoring activities, ensuring compliance with relevant regulations and Standard Operating Procedures (SOPs).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 Medical Operations Leader (MOL) activities as required
Inform Line Manager (LM)/Team Manager, Medical Operations Leader (MOL) or Project Leader (PL) and Regional Head of PV Operations of potential change-in-scope of projects
Support of Medical Directors/Safety Physicians, as needed, in medical monitoring activities
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 AssistantsQualificationsAnalytical 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 ie.Argus or Aris G

Education (one of)
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

Language Skills
Fluent English

Minimum Work Experience
Related experience gained in a healthcare environment is an advantageEEO DisclaimerPAREXEL complies with all applicable federal, state, and local laws prohibiting discrimination in employment. All qualified applicants will receive consideration for employment without regard to gender, age, race, color, religious creed, marital status, sexual orientation, national origin, ethnicity, ancestry, citizenship, genetic information, disability, protected veteran status or any other characteristic protected by applicable federal, state or local law.