Drug Safety Associate Job at Parexel Mohali | Pharma Apply!
Parexel is hiring a Drug Safety Associate I for its Mohali, India location. This full-time opportunity invites individuals pas
sionate about healthcare, clinical trials, and patient safety to contribute to life-saving therapies. With just 5 days left to apply (deadline: April 16, 2025), now’s your chance to be part of a purpose-driven global team committed to improving health outcomes worldwide.Job Posting: Drug Safety Associate I
Locations: India-Mohali
Time Type: Full-time
Posted on: Today
Time Left to Apply: End Date: April 16, 2025 (5 days left to apply)
Job Requisition ID: R0000032772
About Parexel
When our values align, there’s no limit to what we can achieve.
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 developing 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.
Job Description
Key Accountabilities as Drug Safety Associate:
- Assist in the 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 the 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 reports, and project central files.
- Assist with additional Drug Safety Specialist and/or Safety Service Project Leader (SSPL) activities as required.
- Inform the Line Manager (LM)/Team Manager, Safety Services Project Leader (SSPL) or Project Leader (PL), and the Regional Head of PV Operations of potential changes in the 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 the development of Expedited Reporting Procedures
- Assistance with registration with relevant authorities for electronic reporting on behalf of the 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 the unblinding of SUSARs, as required
- Support the 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 Required for Drug Safety Associate:
Degree in Pharmacy, Nursing, Life Science, or other health-related field, or equivalent qualification/work experience
Associate’s degree in any of the above with appropriate work experience
Keywords: Drug Safety Associate, Parexel, Healthcare, Job Posting, Clinical Trials, Drug Safety Management, Regulatory Compliance
