Teva is hiring for the position of GPV Professional, Case Processing in Bangalore, India. The role focuses on pharmacovigilance case processing, adverse event evaluation, medical coding, safety database activities, regulatory compliance, data quality, and process improvement.
Job Details
| Details | Information |
|---|---|
| Company | Teva |
| Position | GPV Professional, Case Processing |
| Location | Bangalore, India |
| Job ID | 70380 |
| Education | M.Pharm, Pharm.D, B.Pharm, BDS |
Responsibilities
- Process serious and non-serious adverse events from various post-marketing sources.
- Perform accurate and consistent medical coding using MedDRA (Medical Dictionary for Regulatory Activities).
- Verify data between source documents and the Safety Database.
- Evaluate events and suspect drug coding, seriousness, causality, listedness, and narrative writing.
- Evaluate the need for follow-ups and queries with stakeholders to ensure accurate data transfer.
- Analyze quality data for trending and process stabilization.
- Take responsibility for assigned case-processing activities on a day-to-day basis.
- Coordinate with internal and external stakeholders to obtain information required for operations.
- Provide real-time status updates to the reporting manager.
- Maintain effective communication with internal departments and external partners, authorities, and vendors.
- Assist with Safety Database administrative and procedural activities.
- Perform assigned tasks in compliance with work instructions and GVP modules.
- Evaluate the quality of case processing and identify trends for process improvement.
- Meet compliance metrics including case timelines, assigned training, and turnaround time (TAT).
- Provide analytical support to peers and managers for investigations and trend analysis related to audits and inspections.
- Mentor and train new hires on case-processing activities and evaluate their progress during the initial learning period.
Eligibility / Qualifications
Candidates should have any of the following educational qualifications:
- M.Pharm
- Pharm.D
- B.Pharm
- BDS
Candidates should also have knowledge of:
- Medical terminology
- Clinical pharmacology
- Diagnostic investigations
- Pathology
- Pharmacovigilance principles
- International regulatory requirements related to drug and patient safety
- Teva product portfolio and therapeutic areas
- Mechanisms of action
- Product and patient safety
Required Skills
- Strong knowledge of pharmacovigilance principles
- Understanding of international drug and patient safety regulations
- Medical coding knowledge, particularly MedDRA
- Knowledge of Safety Database activities
- Analytical and trend-analysis skills
- Excellent professional English communication skills
- Strong writing and presentation skills
- Attention to detail
- Ability to coordinate with internal and external stakeholders
- Ability to support investigations, audits, and inspections
- Case-processing training and mentoring capabilities
Application Details
