Parexel Hiring Drug Safety Associate I in Pharmacovigilance
About Company
At Parexel, we are dedicated to improving global health. From clinical trials to regulatory, consulting, and market access, our clinical development solutions are driven by our mission to benefit patients. Each role at Parexel is personal, empathetic, and committed to making a difference.
Position Name:
Drug Safety Associate I
Organization:
Parexel
Qualification:
BDS, M.Pharm
Experience:
0 YEARS / Freshers – 2 Year
Salary:
₹4.9 Lakhs per year
Location:
Chandigarh, India (Office Based)
Key Accountabilities:
| Area | Responsibilities |
|---|---|
| Drug Safety Support | – Assist in developing project-specific safety procedures, workflows, and templates. – Aid in safety database setup, data entry guidelines development, and user acceptance testing. – Triage incoming reports for completeness and validity. – Document and quality control drug safety information electronically. – Enter case reports into safety database/tracking system. – Manage follow-up requests and queries. – Code data in the safety database. – Write case narratives. – Maintain project-specific working files and case report files. |
| Team Support | – Support Drug Safety Specialists and Safety Service Project Leaders as required. – Inform managers of potential project scope changes. – Support Medical Directors and Safety Physicians in medical monitoring. – Participate in client and investigator meetings. – Attend training sessions. – Perform literature searches. – Prepare for and follow up on audits and inspections. – Delegate work to Drug Safety Assistants. |
| Reporting | – Develop Expedited Reporting Procedures. – Register with authorities for electronic reporting on behalf of sponsors. – Set up and deploy worldwide reporting to regulatory authorities. – Submit safety reports to investigators. – Track and file submission cases. – Assist with unblinding of SUSARs. – Review metrics for reporting compliance. |
Skills:
- Analytical and problem-solving skills.
- Ability to perform database/literature searches.
- Excellent interpersonal, verbal, and written communication skills.
- Strong organizational and prioritization skills.
- Ability to work effectively in a team environment.
- Client-focused approach.
- Experience with computer applications.
Apply now to join a team committed to making a difference in global health.