Cognizant has announced an exciting opportunity for experienced pharmacovigilance professionals by opening applications for the position of SPE – Pharmacovigilance in Mumbai, India. Candidates with 1 to 4 years of pharmacovigilance case processing experience and a Bachelor’s or Master’s degree in Pharmacy are encouraged to apply.
This hybrid opportunity is ideal for professionals with expertise in ICSR processing, Argus Safety Database, MedDRA coding, EudraVigilance, literature case processing, and global pharmacovigilance regulations. Experience in therapeutic areas such as Cardiovascular, Neuroscience, Oncology, Immunology, and Gene Therapy will be an added advantage.
Job Details
- Position: SPE – Pharmacovigilance
- Job ID: 00069182951
- Company: Cognizant
- Location: Mumbai, Maharashtra, India
- Work Model: Hybrid
- Experience Required: 1-4 Years
- Qualification: Bachelor’s or Master’s Degree in Pharmacy
- Department: Technology & Engineering
- Date Posted: 17 June 2026
Key Responsibilities
- Perform triage and intake of ICSRs in Argus databases within defined timelines.
- Download and monitor valid ICSRs from EudraVigilance and other sources.
- Process literature, spontaneous, clinical trial, and solicited cases.
- Conduct literature searches for valid ICSRs using literature search tools.
- Generate safety 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, update narratives, and label events appropriately.
- Obtain follow-up information for case completion as per regulatory requirements.
- Submit processed cases to regulatory authorities and distribute reports to partners.
- Collaborate effectively with clients and internal stakeholders.
- Participate in internal and client training sessions.
- Ensure compliance with GCP, GVP, ICH guidelines, SOPs, and industry standards.
- Support SOP development and continuous process improvement initiatives.
- Troubleshoot process-related issues and ensure smooth pharmacovigilance operations.
- Work in rotational shifts to support global operations.
Qualifications and Skills Required
- Bachelor’s or Master’s degree in Pharmacy (B.Pharm, M.Pharm).
- Minimum 1 year of relevant experience in pharmacovigilance case processing.
- Hands-on experience with Argus Safety Database and ICSR processing.
- Good understanding of EudraVigilance and literature case management.
- Strong knowledge of GCP, GVP, ICH guidelines, and global pharmacovigilance regulations.
- Knowledge of medical terminology and MedDRA coding.
- Proficiency in Microsoft Word, Excel, PowerPoint, and web-based applications.
- Excellent communication, organizational, and time management skills.
- High attention to detail and commitment to quality standards.
- Ability to work independently and take initiative.
Preferred Experience
Candidates with experience in the following therapeutic areas will have an advantage:
- Cardiovascular (CVS)
- Neuroscience (CNS)
- Oncology
- Immunology
- Gene Therapy
- Experience with global pharmaceutical sponsors
Why Join Cognizant?
- Opportunity to work with one of the world’s leading technology and healthcare services organizations.
- Exposure to global pharmacovigilance operations and regulatory reporting.
- Hybrid working model offering flexibility and collaboration.
- Continuous learning and professional development opportunities.
- Work with international clients and cross-functional teams.
- Competitive compensation and career growth opportunities.