In a PAREXEL Pharmacovigilance job, you’ll deliver patient safety services to help bio/pharmaceutical companies meet increasing safety obligations. You will support operational requirement changes, help lower safety monitoring costs, and ensure the team meets all regulatory requirements and post-authorization commitments. Help deliver the next generation of Pharmacovigilance services with a leader in product safety services and solutions
Job Title : Drug Safety Associate
Job ID : 38083BR
Job Description:
- 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 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
Qualifications
- 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 experience