India's DMPLOI - Jobs & Networking AppCognizant is hiring Junior Data Analysts (Pharmacovigilance) for its Mumbai (Hybrid) location. This is an excellent opportunity for B.Pharm/M.Pharm graduates with 1–4 years of pharmacovigilance case processing experience and hands-on expertise in ARGUS Safety Database.
Contents
Job Details
| Company | Cognizant |
|---|---|
| Job Title | Junior Data Analyst – Pharmacovigilance |
| Job Code | SPE-Pharmacovigilance – 00069182951 |
| Location | Mumbai, India |
| Work Model | Hybrid |
| Experience | 1–4 Years |
| Qualification | Bachelor’s or Master’s Degree in Pharmacy |
Key Responsibilities
- Perform triage and intake of ICSRs in the ARGUS database within agreed timelines.
- Download and monitor valid ICSRs from EudraVigilance (EV) and other reporting sources.
- Process literature, spontaneous, clinical trial, and solicited safety cases.
- Search for valid ICSRs using literature search tools.
- Generate reports and submit them to health authorities and business partners.
- Enter serious and non-serious ICSRs into ARGUS with high accuracy.
- Code adverse events, indications, and patient history using MedDRA.
- Code suspect products, amend narratives, and update labeled events.
- Obtain follow-up information for all safety cases as per applicable guidelines.
- Submit processed cases to regulatory authorities and distribute reports to partners.
- Communicate effectively with client stakeholders and internal teams.
- Participate in internal and client training programs.
- Ensure compliance with GCP, GVP, ICH Guidelines, SOPs, and regulatory requirements.
- Assist in developing and maintaining Standard Operating Procedures (SOPs).
- Support team training and process improvement initiatives.
- Troubleshoot process-related issues to ensure smooth operations.
- Work in rotational shifts supporting global pharmacovigilance operations.
Eligibility Criteria
Applicants should have:
- Bachelor’s or Master’s Degree in Pharmacy.
- Minimum 1 year of experience in Pharmacovigilance case processing.
- Experience using ARGUS Safety Database.
- Good understanding of:
- ICSR Case Processing
- MedDRA Coding
- EudraVigilance (EV)
- GCP, GVP & ICH Guidelines
- Good knowledge of medical terminology.
- Strong organizational and time management skills.
- Proficiency in Microsoft Word, Excel, and PowerPoint.
- Excellent written and verbal communication skills.
- High attention to detail and commitment to quality.
Preferred Experience
Candidates with experience in the following therapeutic areas will have an advantage:
- Cardiovascular (CVS)
- Neuroscience (CNS)
- Oncology
- Immunology
- Gene Therapy
Experience working with a global pharmaceutical sponsor will be preferred.
Required Skills
- Pharmacovigilance
- ARGUS Safety Database
- ICSR Processing
- MedDRA Coding
- EudraVigilance (EV)
- Literature Screening
- Regulatory Reporting
- Medical Terminology
- GCP, GVP & ICH Guidelines
- Microsoft Office
- Communication Skills
- Documentation & Quality Compliance
Why Join Cognizant?
- Hybrid work model.
- Opportunity to work on global pharmacovigilance projects.
- Exposure to international regulatory requirements.
- Excellent career growth in drug safety and pharmacovigilance.
- Collaborative and learning-focused work environment.
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