A leading pharmaceutical organization is hiring Senior Associate โ Clinical Safety & Pharmacovigilance (ICSR Submission) for its Noida office. This opportunity is ideal for experienced B.Pharm and M.Pharm professionals with expertise in Individual Case Safety Report (ICSR) submissions, Oracle Argus Safety, E2B(R3) reporting, and global pharmacovigilance compliance.
Candidates with 3โ5 years of Pharmacovigilance (PV) experience and a strong understanding of global regulatory reporting requirements are encouraged to apply.
Job Details
| Particular | Details |
|---|---|
| Position | Senior Associate โ Clinical Safety & Pharmacovigilance |
| Department | Pharmacovigilance / Drug Safety |
| Job Type | Full-Time |
| Experience | 3โ5 Years |
| Qualification | B.Pharm / M.Pharm |
| Location | Noida, India |
Key Responsibilities
The selected candidate will be responsible for:
- Prepare and submit expedited and non-expedited Individual Case Safety Reports (ICSRs).
- Ensure timely safety submissions to global health authorities including FDA, EMA, MHRA, PMDA, Health Canada, and other regulatory agencies.
- Perform quality review of case data, narratives, MedDRA coding, and submission documentation.
- Generate and transmit E2B(R3) electronic reports using pharmacovigilance safety databases.
- Monitor regulatory timelines and ensure compliance with global reporting requirements.
- Track acknowledgments, submission status, and reconciliation activities.
- Collaborate with Case Processing, Medical Review, Regulatory Affairs, and Quality teams.
- Maintain submission records, audit trails, and regulatory documentation.
- Support inspections, audits, and pharmacovigilance compliance activities.
- Participate in SOP improvements and process optimization initiatives.
Required Qualifications
Applicants should possess:
- Bachelor’s or Master’s degree in Pharmacy (B.Pharm/M.Pharm).
- 3โ5 years of Pharmacovigilance or Drug Safety experience.
- Hands-on experience in ICSR submission activities.
- Knowledge of global pharmacovigilance regulations and reporting requirements.
- Experience with Oracle Argus Safety, ArisGlobal LifeSphere, or similar PV systems.
Required Skills
Candidates should have experience with:
- ICSR lifecycle management
- E2B(R2) & E2B(R3) submissions
- MedDRA coding
- WHO Drug coding concepts
- Regulatory reporting timelines
- Microsoft Excel & Word
- Quality control of safety cases
- Strong communication and documentation skills
- Time management and compliance-driven execution
Preferred Skills
Preference will be given to candidates having:
- Gateway submission experience
- Health authority portal knowledge
- ICH E2A, E2B, E2D guidelines
- GVP Modules
- FDA Safety Reporting regulations
- Submission troubleshooting
- PV reconciliation activities
- Pharmacovigilance compliance metrics
Why Join This Opportunity?
- Work on global Pharmacovigilance submissions.
- Exposure to international regulatory authorities.
- Experience with Oracle Argus Safety and E2B(R3) reporting.
- Collaborative work environment.
- Excellent career growth in Clinical Safety and Drug Safety.
- Opportunity to strengthen global regulatory compliance expertise.