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PAREXEL International LLC Drug Safety Associate in Billerica, Massachusetts

Drug Safety Associate

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Job ID61022BRBillerica, Massachusetts

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 Safety Services 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

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 Assistants

Assistance in development of Expedited Reporting Procedures

Assistance with registration with relevant authorities for electronic reporting on behalf of sponsor

Assistance with setting up and deployment of worldwide reporting as required to regulatory authorities, CECs, local ECs, and investigator sites (electronic and hard copy)

Submission of safety reports to investigators via ISIS (International Safety Information System)

Assist with measuring investigative site performance in conducting required tasks in ISIS

Tracking and filing of submission cases as required

Assist with unblinding of SUSARs, as required

Support collection and review of metrics for measuring reporting compliance

Support Global Pharmacovigilance Information Office (GPIO) in the collection and organization of global PV requirements

QualificationsSkills:

· 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 healthcare environment is an advantage

Education:

· Degree in Pharmacy, Nursing, Life Science or other health-related field, or equivalent qualification/work experience

· Associates degree in any of the above with appropriate work experienceEEO DisclaimerParexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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