Global IT and professional services company Cognizant is hiring for the position of SPE-Pharmacovigilance in Mumbai, India. This pharmacovigilance job is ideal for pharmacy graduates and postgraduates with 2-4 years of experience in ICSR case processing, Argus Safety database management, and global drug safety operations.
Candidates with experience in case processing, literature review, MedDRA coding, and regulatory reporting can apply for this exciting opportunity with one of the world’s leading healthcare and life sciences employers.
Job Details
- Company: Cognizant
- Position: SPE-Pharmacovigilance
- Location: Mumbai, Maharashtra, India
- Experience: 2-4 Years
- Employment Type: Full-Time, Permanent
- Industry: IT Services & Consulting
- Department: Healthcare & Life Sciences
- Role Category: Health Informatics
Key Responsibilities
As an SPE-Pharmacovigilance professional, you will:
- Triage and intake Individual Case Safety Reports (ICSRs) in Argus databases within timelines.
- Download and monitor valid ICSRs from EudraVigilance and other safety databases.
- Process spontaneous, literature, clinical trial, and solicited adverse event cases.
- Perform literature searches to identify valid safety cases.
- Generate reports and submit them to regulatory authorities and business partners.
- Enter serious and non-serious ICSRs accurately in Argus Safety.
- Code adverse events, indications, and medical history using MedDRA.
- Amend narratives and label events according to client SOPs and work instructions.
- Obtain follow-up information for case completeness.
- Ensure compliance with Good Pharmacovigilance Practices (GVP), Good Clinical Practice (GCP), and ICH guidelines.
- Support SOP development, training initiatives, and process improvements.
- Troubleshoot process-related issues and collaborate with internal and client teams.
- Work in rotational shifts to support global operations.
Eligibility Criteria
Educational Qualification
- Bachelor’s Degree in Pharmacy (B.Pharm)
- Master’s Degree in Pharmacy (M.Pharm)
Experience Required
- Minimum 1 year of relevant experience in pharmacovigilance case processing.
- Overall experience of 2-4 years is preferred.
Preferred Experience
Experience in the following therapeutic areas will be an added advantage:
- Cardiovascular (CVS)
- Neuroscience (CNS)
- Oncology
- Immunology
- Gene Therapy
Experience with global pharmaceutical sponsors is highly preferred.
Required Skills
- Strong knowledge of Argus Safety Database
- Experience in ICSR case processing
- MedDRA coding expertise
- Understanding of EudraVigilance reporting
- Knowledge of GCP, GVP, and ICH guidelines
- Good medical terminology knowledge
- Excellent communication skills
- Strong attention to detail and quality orientation
- Proficiency in Microsoft Word, Excel, and PowerPoint
- Ability to work independently and manage multiple priorities
Why Join Cognizant?
- Opportunity to work with global pharmaceutical and biotechnology clients
- Exposure to international pharmacovigilance operations
- Career growth in drug safety and regulatory reporting
- Continuous learning and professional development programs
- Collaborative work environment with healthcare and life sciences experts
- Exposure to multiple therapeutic areas and advanced safety databases
How to Apply
