Pharmacovigilance Associate
4 days ago
**Key responsibilities of a Pharmacovigilance Associate**:
- **Case Processing**:Receiving, reviewing, and processing individual case safety reports (ICSRs) from various sources like healthcare professionals, clinical trials, and patients.
- **Data Entry and Management**:Accurately capturing adverse event details into specialized safety databases, including patient demographics, medical history, and details of the adverse event.
- **Medical Review**:Assessing the seriousness and potential relationship between the reported adverse event and the medication using medical knowledge and expertise.
- **MedDRA Coding**:Coding adverse events using the Medical Dictionary for Regulatory Activities (MedDRA) to standardize terminology for reporting.
- **Follow-up Investigations**:Contacting healthcare providers or patients to gather additional information regarding adverse events when necessary.
- **Safety Reporting**:Preparing and submitting safety reports to regulatory agencies according to established timelines and guidelines.
- **Signal Detection**:Monitoring for emerging safety signals by analyzing trends in adverse event data
- **Compliance**:Adhering to all relevant pharmacovigilance regulations and company procedures
**Skills and Qualifications**:
- Bachelor's degree in pharmacy, life sciences, or a related field
- Strong understanding of medical terminology and disease states
- Proficiency in data entry and management systems
- Knowledge of MedDRA coding standards
- Excellent communication and interpersonal skills to interact with healthcare professionals
- Attention to detail and ability to work independently and as part of a team
Pay: ₹351,547.40 - ₹1,552,642.50 per year
Work Location: On the road
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