At Parexel, we all share the same goal – to improve the world’s health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special – a deep conviction in what we do.Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we’re committed to making a difference.
- Vacancy details:
- Department: Drug Safety Associate II
- Experience: 8-15 Years
- Qualification: Bachelor’s Degree
Job Description: Greeting From Parexel Private Limited !!!!!!!!
Important Details :
- Location:India-Mohali
- Post of date: 04/09/2024
- Selection Process: The selection will be on the basis of Interview.
- Mode of Interview: Face to Face
- Interview Rounds of Interview: HR
Drug Safety Support:
Assist in development of project specific safety procedures, workflows and template
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 Service 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
Skills:
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:
Minimum of Bachelor’s Degree in relevant discipline (Science, Medical, etc.) with 3 years of pharmaceutical industry experience; or 2 years of pharmaceutical experience within pharmacovigilance. Experience in a quality, compliance or case processing role highly desirable
Understanding of GxP requirements
Global pharmacovigilance experience preferred
Ability to function in a global matrix environment
Excellent communication and writing skills
Ability to achieve deliverables and manage and resolve issues independently
Experience with Microsoft Excel and Microsoft PowerPoint required
