PAREXEL looking for Drug Safety Associate - B.Pharm, B.Sc apply

PAREXEL has supported the Bio-Tech and Pharmaceutical industries in helping the development of new drugs and treatments on a global basis. As a leading global biopharmaceutical service provider, they supply knowledge-based contract research, medical communications and consulting services across a broad range of therapeutic areas to the worldwide pharmaceutical, biotechnology and medical device industries.

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 on 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

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

Additional Information
Qualification : Degree in Pharmacy, Nursing, Life Science
Location : Hyderabad, Telangana, India
Industry Type : Pharma / Healthcare / Clinical research
Job ID : 83246BR
End Date : 15th August, 2022