2coms is inviting applications for Pharmacovigilance ICSR Case Processing Associate (SPE) and Quality Review Associate (SME) positions in Bengaluru. This is an excellent opportunity for professionals with experience in ICSR Case Processing, Drug Safety, Argus Safety, Veeva Safety, MedDRA Coding, and Pharmacovigilance Operations.
Candidates with 1โ5 years of Pharmacovigilance experience and expertise in Argus Safety or Veeva Safety are encouraged to apply.
Job Details
| Particular | Details |
|---|---|
| Company | 2coms |
| Job Role | ICSR Case Processing Associate (SPE) / Quality Review Associate (SME) |
| Location | Bengaluru, Karnataka |
| Job Type | Full Time |
| Industry | Pharmaceutical & Life Sciences |
| Department | Pharmacovigilance |
| Experience | 1โ5 Years |
| Qualification | Graduate/Postgraduate/Doctorate in Life Sciences, Pharmacy, Medical Sciences or equivalent |
Key Responsibilities
ICSR Case Processing Associate (SPE)
- Perform book-in and complete safety case data entry.
- Process Individual Case Safety Reports (ICSRs).
- Prepare accurate case narratives.
- Perform medical coding and product coding using MedDRA.
- Conduct self-quality checks using Online QC tools.
- Handle case routing and workflow management.
- Perform unblinding activities when required.
- Complete case lock and closure.
- Apply USPI labeling requirements.
- Ensure compliance with global pharmacovigilance guidelines.
Quality Review Associate (SME)
- Perform post-lock and QC review of safety cases.
- Review serious and fatal adverse event cases.
- Track daily quality metrics.
- Communicate quality findings with case processing teams.
- Identify recurring quality issues.
- Drive continuous quality improvement initiatives.
- Maintain compliance with regulatory requirements.
Eligibility Criteria
Applicants should possess:
- B.Pharm
- M.Pharm
- Pharm.D
- B.Sc Life Sciences
- M.Sc Life Sciences
- MBBS
- BDS
- Nursing
- Biotechnology
- Other relevant Medical or Life Sciences qualifications
Required Skills
- Pharmacovigilance
- ICSR Case Processing
- Drug Safety
- Argus Safety
- Veeva Safety
- MedDRA Coding
- Medical Coding
- Product Coding
- Narrative Writing
- Quality Review
- Clinical Research
- Case Processing
- Data Entry
- ICH-GCP Guidelines
- Safety Database Management
- English Communication
- Analytical Skills
- Presentation Skills
- Team Collaboration
Why Join 2coms?
- Opportunity to work on global pharmacovigilance projects.
- Exposure to Argus Safety and Veeva Safety platforms.
- Career growth in Drug Safety and Pharmacovigilance.
- Permanent full-time role.
- Collaborative work environment.
- Gain experience with global regulatory standards.
Salary
Based on current Pharmacovigilance market trends in Bengaluru, the expected salary is:
โน4.5 LPA โ โน9.5 LPA (Depending on experience, skillset, and interview performance.)
How to Apply
