Apply for Drug Safety Associate at PAREXEL @ Apply Now

Post : Drug Safety Associate

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

Candidate Profile
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 in Pharmacovigilance.

Additional Information:
Location: Hyderabad, Telangana
Education: B.Pharm, B.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Job ID : 51603BR
End Date: 10th April, 2019